Versana Balance
Device Facts
| Record ID | K191792 |
|---|---|
| Device Name | Versana Balance |
| Applicant | GE Medical Systems Ultrasound and Primary Care Diagnostics |
| Product Code | IYN · Radiology |
| Decision Date | Aug 9, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The Versana Balance is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Versana Balance clinical applications include: Fetal/Obstetrics, Abdominal (includes GYN and Urological/Prostate), Pediatric, Small Organ (includes breast, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vasculoskeletal Conventional, Musculoskeletal Superficial, Thoracic/Pleural, Transcranial, Transrectal, Transvaginal, and Tissue Biopsy/Fluid Drainage.
Device Story
Versana Balance is a mobile, general-purpose diagnostic ultrasound system for use by trained healthcare professionals in clinical settings. It acquires, processes, and displays ultrasound images using various transducers (convex, linear, sector, mechanical 4D). Input sources include operator control panel (function keys, trackball, keyboard) and external ECG module for gating. The system operates on AC power or internal battery. It supports data export via DVD, USB, LAN, or WiFi, and Bluetooth for patient data sharing. Output is displayed on a monitor for clinical review. Healthcare providers use the system for real-time imaging, measurement, and analysis to guide clinical decisions, such as needle/catheter placement or fluid detection. Benefits include diagnostic visualization and image-guided interventions.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing, including acoustic output measurement, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, electromagnetic, and mechanical safety testing in compliance with AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, and ISO10993-1.
Technological Characteristics
Mobile console with operator control panel, display, and transducers (convex, linear, sector, mechanical 4D). Connectivity: DVD, USB, LAN, WiFi, Bluetooth, HDMI, VGA, S-Video, Composite. Power: AC or internal battery. Standards: AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, ISO10993-1, NEMA UD 2, NEMA PS 3.1-3.20 (DICOM). Biocompatible patient-contact materials. Features include TI-RADS (ACR-based) and standby mode.
Indications for Use
Indicated for qualified healthcare professionals for diagnostic ultrasound imaging, measurement, and analysis of human body and fluid. Clinical applications: Fetal/Obstetrics, Abdominal (GYN/Urological/Prostate), Pediatric, Small Organ (breast/thyroid/testes), Neonatal/Adult Cephalic, Cardiac (Adult/Pediatric), Peripheral Vascular, Musculoskeletal (Conventional/Superficial), Thoracic/Pleural, Transcranial, Transrectal, Transvaginal, and Tissue Biopsy/Fluid Drainage.
Regulatory Classification
Identification
An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Predicate Devices
- Versana Premier (K182277)
- LOGIQ e (K151028)
- Vivid iq (K181727)
- Venue Go (K183362)
- LOGIQ P9 (K181783)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC % Tracey Ortiz Regulatory Affairs Director 9900 W. Innovation Drive WAUWATOSA WI 53226
### Re: K191792
Trade/Device Name: Versana Balance Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: July 2, 2019 Received: July 3, 2019
Dear Tracey Ortiz:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
August 9, 2019
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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
### Indications for Use
510(k) Number (if known) K191792
#### Device Name
Versana Balance
#### Indications for Use (Describe)
The Versana Balance is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Versana Balance clinical applications include: Fetal/Obstetrics, Abdominal (includes GYN and Urological/Prostate), Pediatric, Small Organ (includes breast, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vasculoskeletal Conventional, Musculoskeletal Superficial, Thoracic/Pleural, Transcranial, Transrectal, Transvaginal, and Tissue Biopsy/Fluid Drainage.
| Type of Use (Select one or both, as applicable) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><div><span style="font-size: 20px;">☑</span></div><div>Prescription Use (Part 21 CFR 801 Subpart D)</div></div> |
| <div style="display:flex; align-items:center;"><div>□</div><div>Over-The-Counter Use (21 CFR 801 Subpart C)</div></div> |
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a blue circle. The letters are stylized with curved lines, and the circle has a white outline.
## Indications for Use Forms
The following forms represent indications with clinical applications and exam types along with the modes of operation for the Versana Balance. Combinations identified "P" represents those previously cleared with another GE Ultrasound system. Combinations identified as "N" are new.
The following Indication for Use forms are appended:
System: Versana Balance Transducer: 3Sc-RS Transducer: 6S-RS Transducer: 4C-RS Transducer: 8C-RS Transducer: E8C-RS Transducer: E8Cs-RS Transducer: L6-12-RS Transducer: 12L-RS Transducer: LK760-RS Transducer: RAB2-6-RS
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Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a blue circle. The letters are stylized and connected, and the blue circle has a textured or slightly shaded appearance.
## GE Versana Balance Ultrasound System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application<br>Anatomy/Region of Interest | B | M | Doppler Modes | | | | | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse | Other |
|----------------------------------------------------|---|---|---------------|----|-------|---------|-------|--------------------|---------------------|----------------|--------|
| | | | PW | CW | Color | Color M | Power | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | N | N | N | N | N | N | N | N | N | N | [4][7] |
| Abdominal[1] | N | N | N | N | N | N | N | N | N | N | [4][7] |
| Pediatric | N | N | N | N | N | N | N | N | N | N | [7] |
| Small Organ [2] | N | N | N | N | N | N | N | N | N | N | [7] |
| Neonatal Cephalic | N | N | N | N | N | N | N | N | N | N | |
| Adult Cephalic | N | N | N | N | N | N | N | N | N | N | |
| Cardiac - Adult | N | N | N | N | N | N | N | N | N | N | [7] |
| Cardiac - Pediatric | N | N | N | N | N | N | N | N | N | N | [7] |
| Peripheral Vascular | N | N | N | N | N | N | N | N | N | N | [7] |
| Musculoskeletal Conventional | N | N | N | N | N | N | N | N | N | N | [7] |
| Musculoskeletal Superficial | N | N | N | N | N | N | N | N | N | N | [7] |
| Thoracic/Pleural[5] | N | N | N | N | N | N | N | N | N | N | [7] |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | N | N | N | N | N | N | N | N | N | N | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | N | N | N | N | N | N | N | N | N | N | [7] |
| Transvaginal | N | N | N | N | N | N | N | N | N | N | [7] |
| Intraoperative | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy/Fluid<br>Drainage[3] | N | N | N | N | N | N | N | N | N | N | [7] |
| Vascular Access[6] | N | N | N | N | N | N | N | N | N | N | [7] |
| Non-vascular access | N | N | N | N | N | N | N | N | N | N | [7] |
N = new indication; P= previously cleared by FDA K182277; P1= previously cleared by FDA K151028;
P2=previously cleared by FDA K183362; P3= previously cleared by FDA K181783;
Notes: [1] Abdominal includes GYN and Urological/Prostate;
[2] Small Organ includes breast, testes, thyroid;
[3] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[4] 3D/4D imaging Mode
[5] For detection of fluid and pleural motion/sliding;
[6] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[7] Image guidance for freehand needle/catheter placement;
[*] Combined modes are B/M, B/ Color M, B/PWD, B/Color/PWD, B/Power/PWD;
[*] Coded Pulse is for digitally encoded harmonics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a blue circle. The letters are white, creating a contrast against the blue background.
### Diagnostic Ultrasound Indications for Use Form
### Versana Balance with 3Sc-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | B | M | Doppler Modes | | | | | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse | Other | |
|------------------------------|----|----|---------------|----|-------|---------|-------|--------------------|---------------------|----------------|-------|-----|
| Anatomy/Region of Interest | | | PW | CW | Color | Color M | Power | | | | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | | |
| Abdominal [1] | P | P | P | | P | | P | | P | P | [7] | |
| Pediatric | | | | | | | | | | | | |
| Small Organ [2] | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | p1 | p1 | p1 | p1 | p1 | p1 | p1 | | p1 | p1 | p1 | |
| Cardiac - Adult | P | P | P | P | P | P | P | | P | P | P | [7] |
| Cardiac - Pediatric | P | P | P | P | P | P | P | | P | P | P | [7] |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculoskeletal Conventional | | | | | | | | | | | | |
| Musculoskeletal Superficial | | | | | | | | | | | | |
| Thoracic/Pleural[5] | p1 | p1 | p1 | | p1 | | p1 | | p1 | p1 | p1 | [7] |
| Other | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transcranial | P | P | P | P | P | P | P | | P | P | P | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | | |
| Tissue Biopsy/Fluid | | | | | | | | | | | | |
| Drainage[3] | P | p1 | p1 | | P | p1 | P | | P | P | P | [7] |
| Vascular Access[6] | p1 | p1 | p1 | | p1 | p1 | p1 | | p1 | p1 | p1 | [7] |
| Non-vascular access | N | N | N | | N | N | N | | N | N | N | [7] |
N = new indication; P= previously cleared by FDA K182277; P1= previously cleared by FDA K151028 ; P= previously cleared by FDA K183362; P3= previously cleared by FDA K181783;
[1] Abdominal includes GYN and Urological/Prostate; Notes:
[2] Small Organ includes breast, testes, thyroid;
[3] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[4] 3D/4D imaging Mode
[5] For detection of fluid and pleural motion/sliding;
[6] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[7] Image guidance for freehand needle/catheter placement;
[*] Combined modes are B/M, B/ Color M, B/PWD, B/Color/PWD, B/Power/PWD;
[*] Coded Pulse is for digitally encoded harmonics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a blue circle. The letters are white, and the circle has a slightly lighter blue outline, giving it a three-dimensional appearance.
### Diagnostic Ultrasound Indications for Use Form
### Versana Balance with 6S-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | |
|------------------------------------|-------------------|----|---------------------------|-----------------|------------------|-------------|-------|
| Clinical Application | B | M | Doppler Modes | Combined Modes* | Harmonic Imaging | Coded Pulse | Other |
| | | | PW CW Color Color M Power | | | | |
| Anatomy/Region of Interest | | | | | | | |
| Ophthalmic | | | | | | | |
| Fetal / Obstetrics | | | | | | | |
| Abdominal[1] | | | | | | | |
| Pediatric | P | P | P P P | P | P | P | |
| Small Organ [2] | | | | | | | |
| Neonatal Cephalic | P1 | P1 | P1 P1 | P1 | P1 | P1 | |
| Adult Cephalic | | | | | | | |
| Cardiac - Adult | | | | | | | |
| Cardiac - Pediatric | P | P | P P P P | P | P | P | |
| Peripheral Vascular | | | | | | | |
| Musculoskeletal Conventional | | | | | | | |
| Musculoskeletal Superficial | | | | | | | |
| Thoracic/Pleural[5] | | | | | | | |
| Other | | | | | | | |
| Exam Type, Means of Access | | | | | | | |
| Transcranial | P | P | P P P P | P | P | P | |
| Transesophageal | | | | | | | |
| Transrectal | | | | | | | |
| Transvaginal | | | | | | | |
| Intraoperative | | | | | | | |
| Interventional Guidance | | | | | | | |
| Tissue Biopsy/Fluid<br>Drainage[3] | | | | | | | |
| Vascular Access[6] | | | | | | | |
| Non-vascular access | | | | | | | |
N = new indication; P= previously cleared by FDA K182277; P1= previously cleared by FDA K151028; P2=previously cleared by FDA K183362; P3= previously cleared by FDA K181783;
[1] Abdominal includes GYN and Urological/Prostate; Notes:
- [2] Small Organ includes breast, testes, thyroid;
- [3] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[4] 3D/4D imaging Mode
[5] For detection of fluid and pleural motion/sliding;
[6] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[7] Image guidance for freehand needle/catheter placement;
[*] Combined modes are B/M, B/ Color M, B/PWD, B/Color/PWD, B/Power/PWD;
[*] Coded Pulse is for digitally encoded harmonics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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Image /page/8/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized, cursive font. The logo is enclosed within a circular border that has a pattern of swirling lines around the letters. The color of the logo and the border is a light blue.
### Diagnostic Ultrasound Indications for Use Form Versana Balance with 4C-RS Transducer
| Clinical Application | B | M | Doppler Modes | | | | | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse | Other |
|------------------------------------|----|----|---------------|----|-------|---------|-------|--------------------|---------------------|----------------|-------|
| Anatomy/Region of Interest | | | PW | CW | Color | Color M | Power | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | P | P | P | | P | | P | P | P | P | [7] |
| Abdominal[1] | P | P | P | | P | | P | P | P | P | [7] |
| Pediatric | P | P | P | | P | | P | P | P | P | [7] |
| Small Organ [2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac - Adult | | | | | | | | | | | |
| Cardiac - Pediatric | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | | P | P | P | P | [7] |
| Musculoskeletal Conventional | P | P | P | | P | | P | P | P | P | [7] |
| Musculoskeletal Superficial | | | | | | | | | | | |
| Thoracic/Pleural[5] | P1 | P1 | P1 | | P1 | | P1 | P1 | P1 | P1 | [7] |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy/Fluid<br>Drainage[3] | P | P1 | P1 | | P | | P | P | P | P | [7] |
| Vascular Access[6] | N | N | N | | N | | N | N | N | N | [7] |
| Non-vascular access | P | N | N | | N | | N | P | P | P | [7] |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P= previously cleared by FDA K182277; P1= previously cleared by FDA K151028; P2=previously cleared by FDA K183362; P3= previously cleared by FDA K181783;
[1] Abdominal includes GYN and Urological/Prostate; Notes:
- [2] Small Organ includes breast, testes, thyroid;
[3] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[4] 3D/4D imaging Mode
- [5] For detection of fluid and pleural motion/sliding;
- [6] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[7] Image guidance for freehand needle/catheter placement;
[*] Combined modes are B/M, B/ Color M, B/PWD, B/Color/PWD, B/Power/PWD;
[*] Coded Pulse is for digitally encoded harmonics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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Image /page/9/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a blue circle. The letters are stylized and connected, creating a recognizable and iconic symbol for the company.
### Diagnostic Ultrasound Indications for Use Form Versana Balance with 8C-RS Transducer
| Clinical Application | B | M | Doppler Modes | | | | | Combined<br>Modes* | Harmonic Imaging | Coded Pulse | Other |
|------------------------------------|----|----|---------------|----|-------|---------|-------|--------------------|------------------|-------------|-------|
| Anatomy/Region of Interest | | | PW | CW | Color | Color M | Power | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal[1] | | | | | | | | | | | |
| Pediatric | P | P | P | | P | | P | P | P | P | |
| Small Organ [2] | | | | | | | | | | | |
| Neonatal Cephalic | P1 | P1 | P1 | | P1 | | P1 | P1 | P1 | P2 | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac - Adult | | | | | | | | | | | |
| Cardiac - Pediatric | P | P | P | | P | | P | P | P | P | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculoskeletal Conventional | P | P | P | | P | | P | P | P | P | |
| Musculoskeletal Superficial | | | | | | | | | | | |
| Thoracic/Pleural[5] | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy/Fluid<br>Drainage[3] | | | | | | | | | | | |
| Vascular Access[6] | | | | | | | | | | | |
| Non-vascular access | | | | | | | | | | | |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P= previously cleared by FDA K182277; P1= previously cleared by FDA K151028; P2=previously cleared by FDA K183362; P3= previously cleared by FDA K181783;
Notes: [1] Abdominal includes GYN and Urological/Prostate;
[2] Small Organ includes breast, testes, thyroid;
- [3] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[4] 3D/4D imaging Mode
[5] For detection of fluid and pleural motion/sliding;
[6] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[7] Image guidance for freehand needle/catheter placement;
[*] Combined modes are B/M, B/ Color M, B/PWD, B/Color/PWD, B/Power/PWD;
[*] Coded Pulse is for digitally encoded harmonics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a blue circle. The letters are stylized and connected, creating a unique and recognizable design.
### Diagnostic Ultrasound Indications for Use Form
### Versana Balance with E8C-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|------------------------------------|-------------------|----|----|----|-------|---------|-------|--------------------|---------------------|-----------------|-------|
| Clinical Application | B | M | PW | CW | Color | Color M | Power | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse• | Other |
| Anatomy/Region of Interest | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | P | P | P | | P | | P | P | P | P | [7] |
| Abdominal[1] | P | P | P | | P | | P | P | P | P | [7] |
| Pediatric | | | | | | | | | | | |
| Small Organ [2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac - Adult | | | | | | | | | | | |
| Cardiac - Pediatric | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculoskeletal Conventional | | | | | | | | | | | |
| Musculoskeletal Superficial | | | | | | | | | | | |
| Thoracic/Pleural[5] | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | P | P | P | | P | | P | P | P | P | [7] |
| Transvaginal | P | P | P | | P | | P | P | P | P | [7] |
| Intraoperative | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy/Fluid<br>Drainage[3] | P | P1 | P1 | | P | | P | P | P | P | [7] |
| Vascular Access[6] | N | N | N | | N | | N | N | N | N | [7] |
| Non-vascular access | N | N | N | | N | | N | N | N | N | [7] |
N = new indication; P= previously cleared by FDA K182277; P1= previously cleared by FDA K151028; P2=previously cleared by FDA K183362; P3= previously cleared by FDA K181783;
[1] Abdominal includes GYN and Urological/Prostate; Notes:
- [2] Small Organ includes breast, testes, thyroid;
[3] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[4] 3D/4D imaging Mode
[5] For detection of fluid and pleural motion/sliding;
[6] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[7] Image guidance for freehand needle/catheter placement;
[*] Combined modes are B/M, B/ Color M, B/PWD, B/Color/PWD, B/Power/PWD;
[*] Coded Pulse is for digitally encoded harmonics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a blue circle. The letters are stylized and appear to be handwritten or cursive. The blue color of the circle is a light shade.
### Diagnostic Ultrasound Indications for Use Form
### Versana Balance with E8Cs-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse | Other |
|------------------------------------|-------------------|---|---------------|----|-------|---------|-------|--------------------|---------------------|----------------|-------|
| | B | M | Doppler Modes | | | | | | | | |
| | | | PW | CW | Color | Color M | Power | | | | |
| <i>Anatomy/Region of Interest</i> | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | P | P | P | | P | | P | P | P | P | [7] |
| Abdominal[1] | P | P | P | | P | | P | P | P | P | [7] |
| Pediatric | | | | | | | | | | | |
| Small Organ [2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac - Adult | | | | | | | | | | | |
| Cardiac - Pediatric | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculoskeletal Conventional | | | | | | | | | | | |
| Musculoskeletal Superficial | | | | | | | | | | | |
| Thoracic/Pleural[5] | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| <i>Exam Type, Means of Access</i> | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | P | P | P | | P | | P | P | P | P | [7] |
| Transvaginal | P | P | P | | P | | P | P | P | P | [7] |
| Intraoperative | | | | | | | | | | | |
| <i>Interventional Guidance</i> | | | | | | | | | | | |
| Tissue Biopsy/Fluid<br>Drainage[3] | P | P | P | | P | | P | P | P | | [7] |
| Vascular Access[6] | N | N | N | | N | | N | N | N | | [7] |
| Non-vascular access | N | N | N | | N | | N | N | N | | [7] |
N = new indication; P= previously cleared by FDA K182277; P1= previously cleared by FDA K151028; P2=previously cleared by FDA K183362; P3= previously cleared by FDA K181783;
[1] Abdominal includes GYN and Urological/Prostate; Notes:
[2] Small Organ includes breast, testes, thyroid;
[3] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[4] 3D/4D imaging Mode
[5] For detection of fluid and pleural motion/sliding;
[6] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[7] Image guidance for freehand needle/catheter placement;
[*] Combined modes are B/M, B/ Color M, B/PWD, B/Color/PWD, B/Power/PWD;
[*] Coded Pulse is for digitally encoded harmonics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a blue circle. The letters are white, creating a contrast against the blue background.
### Diagnostic Ultrasound Indications for Use Form
### Versana Balance with L6-12-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|------------------------------------|-------------------|----|----|----|-------|---------|-------|--------------------|---------------------|----------------|-------|
| Clinical Application | B | M | PW | CW | Color | Color M | Power | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse | Other |
| Anatomy/Region of Interest | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal[1] | | | | | | | | | | | |
| Pediatric | P | P3 | P | | P | | P | P | P | P | [7] |
| Small Organ [2] | P | P3 | P | | P | | P | P | P | P | [7] |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac - Adult | | | | | | | | | | | |
| Cardiac - Pediatric | | | | | | | | | | | |
| Peripheral Vascular | P | P3 | P | | P | | P | P | P | P | [7] |
| Musculoskeletal Conventional | P | P3 | P | | P | | P | P | P | P | [7] |
| Musculoskeletal Superficial | P | P3 | P | | P | | P | P | P | P | [7] |
| Thoracic/Pleural[5] | N | N | N | | N | | N | N | N | N | [7] |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy/Fluid<br>Drainage[3] | P | N | N | | P | | P | P | P | P | [7] |
| Vascular Access[6] | P | N | N | | P | | P | P | P | P | [7] |
| Non-vascular access | P | N | N | | N | | N | P | P | P | [7] |
N = new indication; P= previously cleared by FDA K182277; P1= previously cleared by FDA K151028; P2=previously cleared by FDA K183362; P3= previously cleared by FDA K181783;
Notes: [1] Abdominal includes GYN and Urological/Prostate;
[2] Small Organ includes breast, testes, thyroid;
[3] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[4] 3D/4D imaging Mode
[5] For detection of fluid and pleural motion/sliding;
[6] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[7] Image guidance for freehand needle/catheter placement;
[*] Combined modes are B/M, B/ Color M, B/PWD, B/Color/PWD, B/Power/PWD;
[*] Coded Pulse is for digitally encoded harmonics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
{13}------------------------------------------------
Image /page/13/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a blue circle. The letters are white, and the circle has a slightly lighter blue outline, giving it a three-dimensional appearance.
### Diagnostic Ultrasound Indications for Use Form
### Versana Balance with 12L-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|------------------------------------|-------------------|----|---------------|----|-------|---------|--------------------|---------------------|----------------|-------|
| Clinical Application | B | M | Doppler Modes | | | | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse | Other |
| | | | PW | CW | Color | Color M | Power | | | |
| Anatomy/Region of Interest | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | |
| Abdominal[1] | | | | | | | | | | |
| Pediatric | P | P1 | P | | P | | P | P | P | [7] |
| Small Organ [2] | P | P1 | P | | P | | P | P | P | [7] |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac - Adult | | | | | | | | | | |
| Cardiac - Pediatric | | | | | | | | | | |
| Peripheral Vascular | P | P1 | P | | P | | P | P | P | [7] |
| Musculoskeletal Conventional | P | P1 | P | | P | | P | P | P | [7] |
| Musculoskeletal Superficial | P | P1 | P | | P | | P | P | P | [7] |
| Thoracic/Pleural[5] | P1 | P1 | P1 | | P1 | | P1 | P1 | P1 | [7] |
| Other | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | |
| Transcranial | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Intraoperative | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | |
| Tissue Biopsy/Fluid<br>Drainage[3] | P | P1 | P1 | | P | | P | P | P | [7] |
| Vascular Access[6] | P | P1 | P | | P | | P | P | P | [7] |
| Non-vascular access | P | P2 | P2 | | P2 | | P2 | P | P | [7] |
N = new indication; P= previously cleared by FDA K182277; P1= previously cleared by FDA K151028; P2=previously cleared by FDA K183362; P3= previously cleared by FDA K181783;
Notes: [1] Abdominal includes GYN and Urological/Prostate;
[2] Small Organ includes breast, testes, thyroid;
[3] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[4] 3D/4D imaging Mode
[5] For detection of fluid and pleural motion/sliding;
[6] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[7] Image guidance for freehand needle/catheter placement;
[*] Combined modes are B/M, B/ Color M, B/PWD, B/Color/PWD, B/Power/PWD;
[*] Coded Pulse is for digitally encoded harmonics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
{14}------------------------------------------------
Image /page/14/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a blue circle. The letters are white, creating a contrast against the blue background.
### Diagnostic Ultrasound Indications for Use Form
#### Versana Balance with LK760-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | | | | |
|------------------------------------|---|-------------------|---------------|--|---|--|-------|--------------------|------------------|-------------|-------|--|
| Anatomy/Region of Interest | B | M | Doppler Modes | | | | Power | Combined<br>Modes* | Harmonic Imaging | Coded Pulse | Other | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | | |
| Abdominal[1] | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ [2] | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac - Adult | | | | | | | | | | | | |
| Cardiac - Pediatric | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculoskeletal Conventional | P | P¹ | P | | P | | P | P | P | P | P | |
| Musculoskeletal Superficial | | | | | | | | | | | | |
| Thoracic/Pleural[5] | | | | | | | | | | | | |
| Other | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | | |
| Tissue Biopsy/Fluid<br>Drainage[3] | | | | | | | | | | | | |
| Vascular Access[6] | | | | | | | | | | | | |
| Non-vascular access | | | | | | | | | | | | |
N = new indication; P= previously cleared by FDA K182277; P1= previously cleared by FDA K151028; P2=previously cleared by FDA K183362; P3= previously cleared by FDA K181783;
[1] Abdominal includes GYN and Urological/Prostate; Notes:
- [2] Small Organ includes breast, testes, thyroid;
- [3] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[4] 3D/4D imaging Mode
[5] For detection of fluid and pleural motion/sliding;
- [6] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
- [7] Image guidance for freehand needle/catheter placement;
[*] Combined modes are B/M, B/ Color M, B/PWD, B/Color/PWD, B/Power/PWD;
[*] Coded Pulse is for digitally encoded harmonics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
{15}------------------------------------------------
Image /page/15/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a blue circle. The letters are stylized and appear to be handwritten or cursive. The blue color of the circle is a light shade.
### Diagnostic Ultrasound Indications for Use Form
### Versana Balance with RAB2-6-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | Other |
|------------------------------|-------------------|---|---------------|----|-------|---------|-------|--------|
| | B | M | Doppler Modes | | | | | |
| | | | PW | CW | Color | Color M | Power | |
| Anatomy/Region of Interest | | | | | | | | |
| Ophthalmic | | | | | | | | |
| Fetal / Obstetrics | P | P | P | | P | | P | [4][7] |
| Abdominal[1] | P | P | P | | P | | P | [4][7] |
| Pediatric | | | | | | | | |
| Small Organ [2] | | | | | | | | |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Cardiac - Adult | | | | | | | | |
| Cardiac - Pediatric | | | | | | | | |
| Peripheral Vascular | | | | | | | | |
| Musculoskeletal Conventional | | | | | | | | |
| Musculoskeletal Superficial | | | | | | | | |
| Thoracic/Pleural[5] | | | | | | | | |
| Other | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | |
| Transcranial | | | | | | | | |
| Transesophageal | | | | | | | | |
| Transrectal | | | | | | | | |
| Transvaginal | | | | | | | | |
| Intraoperative | | | | | | | | |
| Interventional Guidance | | | | | | | | |
| Tissue Biopsy/Fluid | | | | | | | | |
| Drainage[3] | P | | | | P | P | P | [7] |
| Vascular Access[6] | | | | | | | | |
| Non-vascular access | | | | | | | | |
N = new indication; P= previously cleared by FDA K182277; P1= previously cleared by FDA K151028; P2=previously cleared by FDA K183362; P3= previously cleared by FDA K181783;
[1] Abdominal includes GYN and Urological/Prostate; Notes:
- [2] Small Organ includes breast, testes, thyroid;
- [3] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[4] 3D/4D imaging Mode
[5] For detection of fluid and pleural motion/sliding;
- [6] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
- [7] Image guidance for freehand needle/catheter placement;
[*] Combined modes are B/M, B/ Color M, B/PWD, B/Color/PWD, B/Power/PWD;
[*] Coded Pulse is for digitally encoded harmonics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)
{16}------------------------------------------------
Image /page/16/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a blue circle. The letters are also blue, matching the color of the circle.
### 510(k) Summary
K191792
| In accordance with 21 CFR 807.92 the following summary of information is provided: | |
|------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | July 2, 2019 |
| Submitter: | GE Medical Systems Ultrasound and Primary Care Diagnostics<br>9900 Innovation Drive<br>Wauwatosa, WI 53226 |
| Primary Contact Person: | Tracey Ortiz<br>Regulatory Affairs Director<br>GE Healthcare<br>T:(262)676-6120 |
| Secondary Contact Person: | Gao Gan<br>Regulatory Affairs<br>GE Healthcare |
| Device Trade Name: | Versana Balance |
| Common/Usual Name: | Diagnostic Ultrasound System |
| Classification Names: | Class II<br>Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90- |
| Product Code:…
