← Product Code [IYN](/productcode/IYN) · K170078
# Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley (K170078)
_Medisono, LLC · IYN · May 17, 2017 · Radiology · SESE_
**Canonical URL:** https://fda-staging.innolitics.com/device/K170078
## Device Facts
- **Applicant:** Medisono, LLC
- **Product Code:** [IYN](/productcode/IYN.md)
- **Decision Date:** May 17, 2017
- **Decision:** SESE
- **Submission Type:** Abbreviated
- **Regulation:** 21 CFR 892.1550
- **Device Class:** Class 2
- **Review Panel:** Radiology
- **Attributes:** Pediatric
## Indications for Use
The Medisono Color Doppler Ultrasound System, models P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley are general purpose ultrasonic intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vasculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gvn and Urology,
## Device Story
The Medisono Color Doppler Ultrasound System (models P11, P12, P25 series) is a general-purpose, software-controlled diagnostic ultrasound system. It transmits ultrasonic energy into the patient's body and processes received echoes to generate real-time images of internal structures and fluid flow. The system supports multiple imaging modes, including B-Mode (with Tissue Harmonic Imaging), M-Mode, TDI, Color-Flow Doppler, Pulsed Wave Doppler, Power Doppler, and 3D/4D imaging. It is used in clinical settings by qualified physicians to evaluate various anatomical regions, including fetal, abdominal, cardiac, and peripheral vascular structures. The system consists of a mobile console or portable unit, a keyboard control panel, a color LCD monitor, and various interchangeable transducers (linear, convex, and phased array). The output is displayed on the monitor, allowing the physician to visualize anatomy and blood flow, which aids in clinical diagnosis and decision-making. The device benefits patients by providing non-invasive, real-time diagnostic imaging.
## Clinical Evidence
No clinical data was required or presented. Substantial equivalence is supported by non-clinical bench testing, including acoustic output measurements per NEMA UD-2 and UD-3 standards, and compliance with electrical safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37).
## Technological Characteristics
All-digital architecture with progressive dynamic receive focusing. Transducer types: linear, convex, and phased array. Frequency range: 1.0 MHz to 15.0 MHz. Modes: B-Mode (with Tissue Harmonic Imaging), M-Mode, TDI, Color-Flow Doppler, Pulsed Wave Doppler, Power Doppler, 3D/4D, and Elastography. Connectivity: mobile console with LCD monitor. Software-controlled.
## Regulatory 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
- Sonoscape S6 ([K112602](/device/K112602.md))
- Sonoscape S8 Exp ([K132768](/device/K132768.md))
- Sonoscape S11 ([K130801](/device/K130801.md))
- Sonoscape S12 ([K152396](/device/K152396.md))
- Sonoscape S20 ([K110510](/device/K110510.md))
- Sonoscape S22 ([K142815](/device/K142815.md))
## Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 17, 2017
MEDISONO, LLC % Jorge Millan, Ph.D. Regulatory Affairs Director HIATEC 601 West 20 Street HIALEAH FL 33010
Re: K170078
Trade/Device Name: Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley
Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: March 1, 2017 Received: March 6, 2017
Dear Dr. Millan:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael D.'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known)
#### K170078
Device Name
Medisono Color Doppler Ultrasound System, models P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley.
Indications for Use (Describe)
The Medisono Color Doppler Ultrasound System, models P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley are general purpose ultrasonic intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vasculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gvn and Urology,
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) — Over-The-Counter Use (21 CFR 801 Subpart C)
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#### Diagnostic Ultrasound Indications for Use Form P11 Portable Ultrasonic Diagnostic Imaging System
| Clinical Application | | Mode of Operation | | | | | | | |
|----------------------------|---------------------------------|-------------------|---|----|----|-------|-------|---------------------------|------------------------|
| General (Track 1
only) | Specific (Tracks 1&3) | B | M | PW | CW | Color | Power | Combined
(Specify) [1] | Other
(Specify) [2] |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging
and Other | Fetal | N | N | N | N | N | N | Note 1 | Note 2,4,5 |
| | Abdominal | N | N | N | N | N | N | Note 1 | Note 2,4,5 |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neurological) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | N | N | N | Note 1 | Note 2,4 |
| | Small Organ (Specify) * | N | N | N | N | N | N | Note 1 | Note 2,4,6 |
| | Neonatal Cephalic | N | N | N | N | N | N | Note 1 | Note 2,4,6 |
| | Adult Cephalic | N | N | N | N | N | N | Note 1 | Note 2,4,6 |
| | Trans-rectal | N | N | N | N | N | N | Note 1 | Note 2,4 |
| | Trans-vaginal | N | N | N | N | N | N | Note 1 | Note 2,4 |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | |
| | Musculo-skeletal (Conventional) | N | N | N | N | N | N | Note 1 | Note 2,4 |
| | Musculo-skeletal (Superficial) | N | N | N | N | N | N | Note 1 | Note 2,4 |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | N | N | N | N | N | N | Note 1 | Note 2,4,5 |
| Cardiac | Cardiac Adult | N | N | N | N | N | N | Note 1 | Note 2,3,4 |
| | Cardiac Pediatric | N | N | N | N | N | N | Note 1 | Note 2,3.4 |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | N | N | N | N | N | N | Note 1 | Note 2,4 |
| | Other (Urology) | | | | | | | | |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M
Note 1: Other Combined includes: B/M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonics, The feature does not use contrast agents
Note 3: TDI Note 4: 3D Note 5: 4D
Note 6: Small Organ: breast, thyroid, testes
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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#### Diagnostic Ultrasound Indications for Use Form P11 Portable with 2PI Phase Array Transducer
| Clinical Application | | | Mode of Operation | | | | | | | | | |
|----------------------------|---------------------------------|---|-------------------|----|----|-------|-------|---------------------------|---------------------------|--|--|--|
| General (Track 1
only) | Specific (Tracks 1&3) | B | M | PW | CW | Color | Power | Combined
(Specify) [1] | Other
(Specify) [2][3] | | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | | |
| Fetal Imaging
and Other | Fetal | | | | | | | | | | | |
| | Abdominal | | | | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | | | | |
| | Intra-operative (Neurological) | | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | | |
| | Pediatric | N | N | N | N | N | N | Note 1 | Note 2,4 | | | |
| | Small Organ (Specify) * | | | | | | | | | | | |
| | Neonatal Cephalic | N | N | N | N | N | N | Note 1 | Note 2,4,6 | | | |
| | Adult Cephalic | | | | | | | | | | | |
| | Trans-rectal | | | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | | | | |
| | Musculo-skeletal (Conventional) | | | | | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | | | | |
| | Intravascular | | | | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | | | |
| | Cardiac Pediatric | N | N | N | N | N | N | Note 1 | Note 2,3.4 | | | |
| | Intravascular (Cardiac) | | | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | | |
| | Other (Specify) | | | | | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | | | | | | | | | | | |
| | Other (Urology) | | | | | | | | | | | |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M
Note 1: Other Combined includes: B/M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonics, The feature does not use contrast agents
Note 3: TDI Note 4: 3D Note 5: 4D
Note 6: Small Organ: breast, thyroid, testes
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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#### Diagnostic Ultrasound Indications for Use Form P11 Portable with 5PI Phase Array Transducer
| Clinical Application | | | Mode of Operation | | | | | | |
|----------------------------|--------------------------------|---|-------------------|----|----|-------|-------|---------------------------|---------------------------|
| General (Track 1
only) | Specific (Tracks 1&3) | B | M | PW | CW | Color | Power | Combined
(Specify) [1] | Other
(Specify) [2][3] |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging
and Other | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neurological) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | N | N | N | Note 1 | Note 2,4 |
| | Small Organ (Specify) * | | | | | | | | |
| | Neonatal Cephalic | N | N | N | N | N | N | Note 1 | Note 2,4,6 |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card) | | | | | | | | |
| | Musculo-skeletal(Conventional) | | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | N | N | N | N | N | N | Note 1 | Note 2,3.4 |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | | | | | | | | |
| | Other (Urology) | | | | | | | | |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M
Note 1: Other Combined includes: B/M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonics, The feature does not use contrast agents
Note 3: TDI Note 4: 3D Note 5: 4D
Note 6: Small Organ: breast, thyroid, testes
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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#### Diagnostic Ultrasound Indications for Use Form P11 Portable with 6V1 Micro-curved Array Transducer
| Clinical Application | | | Mode of Operation | | | | | | | | |
|----------------------------|--------------------------------|---|-------------------|----|----|-------|-------|---------------------------|---------------------------|--|--|
| General (Track 1
only) | Specific (Tracks 1&3) | B | M | PW | CW | Color | Power | Combined
(Specify) [1] | Other
(Specify) [2][3] | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| Fetal Imaging
and Other | Fetal | | | | | | | | | | |
| | Abdominal | | | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | | | |
| | Intra-operative (Neurological) | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | |
| | Pediatric | | | | | | | | | | |
| | Small Organ (Specify) * | | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | | |
| | Trans-rectal | N | N | N | N | N | N | Note 1 | Note 2,4 | | |
| | Trans-vaginal | N | N | N | N | N | N | Note 1 | Note 2,4 | | |
| | Trans-urethral | | | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | | | |
| | Musculo-skeletal(Conventional) | | | | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | | | |
| | Intravascular | | | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | |
| | Other (Specify) | | | | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | | | | | | | | | | |
| | Other (Urology) | | | | | | | | | | |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M
Note 1: Other Combined includes: B/M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonics, The feature does not use contrast agents
Note 3: TDI Note 4: 3D Note 5: 4D
Note 6: Small Organ breast, thyroid, testes
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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#### Diagnostic Ultrasound Indications for Use Form P11 Portable with 6V3 Micro-curved Array Transducer
| Clinical Application | | | Mode of Operation | | | | | | | |
|----------------------------|--------------------------------|---|-------------------|----|----|-------|-------|---------------------------|--------------------------|--|
| General (Track 1
only) | Specific (Tracks 1&3) | B | M | PW | CW | Color | Power | Combined
(Specify) [1] | Other
(Specify) [2][3 | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal Imaging
and Other | Fetal | | | | | | | | | |
| | Abdominal | | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | | |
| | Intra-operative (Neurological) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | | | | | | | | | |
| | Small Organ (Specify) * | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | N | N | N | N | N | N | Note 1 | Note 2,4 | |
| | Trans-vaginal | N | N | N | N | N | N | Note 1 | Note 2,4 | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | | |
| | Musculo-skeletal(Conventional) | | | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| | Other (Specify) | | | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | | | | | | | | | |
| | Other (Urology) | | | | | | | | | |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M
Note 1: Other Combined includes: B/M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonics, The feature does not use contrast agents
Note 3: TDI Note 4: 3D Note 5: 4D
Note 6: Small Organ breast, thyroid, testes
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
{8}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form P11 Portable with EC9-5 Micro-curved Array Transducer
| Clinical Application | | | Mode of Operation | | | | | | | | |
|----------------------------|--------------------------------|---|-------------------|----|----|-------|-------|---------------------------|---------------------------|--|--|
| General (Track 1
only) | Specific (Tracks 1&3) | B | M | PW | CW | Color | Power | Combined
(Specify) [1] | Other
(Specify) [2][3] | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| Fetal Imaging
and Other | Fetal | | | | | | | | | | |
| | Abdominal | | | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | | | |
| | Intra-operative (Neurological) | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | |
| | Pediatric | | | | | | | | | | |
| | Small Organ (Specify) * | | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | | |
| | Trans-rectal | N | N | N | N | N | N | Note 1 | Note 2,4 | | |
| | Trans-vaginal | N | N | N | N | N | N | Note 1 | Note 2,4 | | |
| | Trans-urethral | | | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | | | |
| | Musculo-skeletal(Conventional) | | | | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | | | |
| | Intravascular | | | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | |
| | Other (Specify) | | | | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | | | | | | | | | | |
| | Other (Urology) | | | | | | | | | | |
#### Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M
Note 1: Other Combined includes: B/M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonics, The feature does not use contrast agents
Note 3: TDI Note 4: 3D Note 5: 4D
Note 6: Small Organ breast, thyroid, testes
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
{9}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form P11 Portable with C611 Micro-curved Array Transducer
| Clinical Application | | | Mode of Operation | | | | | | |
|----------------------------|---------------------------------|---|-------------------|----|----|-------|-------|--------------------------|--------------------------|
| General (Track 1
only) | Specific (Tracks 1&3) | B | M | PW | CW | Color | Power | Combined[1]
(Specify) | Other[2][3]
(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging
and Other | Fetal | | | | | | | | |
| | Abdominal | N | N | N | | N | N | Note 1 | Note 2,4 |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neurological) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | | N | N | Note 1 | Note 2,4 |
| | Small Organ (Specify) * | | | | | | | | |
| | Neonatal Cephalic | N | N | N | | N | N | Note 1 | Note 2,3,4 |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card) | | | | | | | | |
| | Musculo-skeletal (Conventional) | | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | N | N | N | | N | N | Note 1 | Note 2,3,4 |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | | | | | | | | |
| | Other (Urology) | | | | | | | | |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M
Note 1: Other Combined includes: B/M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonics, The feature does not use contrast agents
Note 3: TDI Note 4: 3D Note 5: 4D
Note 6: Small Organ breast, thyroid, testes
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
{10}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form P11 Portable with C611 Micro-curved Array Transducer
| | Clinical Application | Mode of Operation | | | | | | | |
|----------------------------|--------------------------------|-------------------|---|----|----|-------|-------|---------------------------|--------------------------|
| General (Track 1
only) | Specific (Tracks 1&3) | B | M | PW | CW | Color | Power | Combined
(Specify) [1] | Other
(Specify) [2][3 |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging
and Other | Fetal | | | | | | | | |
| | Abdominal | N | N | N | | N | N | Note 1 | Note 2,4 |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neurological) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | | N | N | Note 1 | Note 2,4 |
| | Small Organ (Specify) * | | | | | | | | |
| | Neonatal Cephalic | N | N | N | | N | N | Note 1 | Note 2,3,4 |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card) | | | | | | | | |
| | Musculo-skeletal(Conventional) | | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | N | N | N | | N | N | Note 1 | Note 2,3,4 |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | | | | | | | | |
| | Other (Urology) | | | | | | | | |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M
Note 1: Other Combined includes: B/M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonics, The feature does not use contrast agents
Note 3: TDI Note 4: 3D Note 5: 4D
Note 6: Small Organ breast, thyroid, testes
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
{11}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form P11 Portable with C362 Curved Array Transducer
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
|--------------------------------------------------------------------------------------------------|--------------------------------|-------------------|---|----|----|-------|-------|---------------------------|---------------------------|
| Clinical Application | | Mode of Operation | | | | | | | |
| General (Track 1
only) | Specific (Tracks 1&3) | B | M | PW | CW | Color | Power | Combined
(Specify) [1] | Other
(Specify) [2][3] |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging
and Other | Fetal | N | N | N | N | N | N | Note 1 | Note 2,4 |
| | Abdominal | N | N | N | N | N | N | Note 1 | Note 2,4 |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neurological) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (Specify) * | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | |
| | Musculo-skeletal(Conventional) | | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | N | N | N | N | N | N | Note 1 | Note 2,4 |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| | Peripheral
Vessel | Peripheral vessel | | | | | | | |
| Other (Urology) | | | | | | | | | |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M
Note 1: Other Combined includes: B/M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonics, The feature does not use contrast agents
Note 3: TDI Note 4: 3D Note 5: 4D
Note 6: Small Organ breast, thyroid, testes
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
{12}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form P11 Portable with C344 Curved Array Transducer
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | Mode of Operation | | | | | | | |
|--------------------------------------------------------------------------------------------------|--------------------------------|-------------------|---|----|----|-------|-------|---------------------------|------------------------|
| Clinical Application | Specific (Tracks 1&3) | B | M | PW | CW | Color | Power | Combined
(Specify) [1] | Other
(Specify) [2] |
| General (Track 1 only) | | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging and Other | Fetal | N | N | N | N | N | N | Note 1 | Note 2,4 |
| | Abdominal | N | N | N | N | N | N | Note 1 | Note 2,4 |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neurological) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (Specify) * | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | |
| | Musculo-skeletal(Conventional) | | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | N | N | N | N | N | N | Note 1 | Note 2,4 |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | | | | | | | | |
| | Other (Urology) | | | | | | | | |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M
Note 1: Other Combined includes: B/M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonics, The feature does not use contrast agents
Note 3: TDI Note 4: 3D Note 5: 4D
Note 6: Small Organ breast, thyroid, testes
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
{13}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form P11 Portable with VC6-2 Curved Array Transducer
| Clinical Application | | | Mode of Operation | | | | | | | |
|----------------------------|---------------------------------|---|-------------------|----|----|-------|-------|---------------------------|---------------------------|--|
| General (Track 1
only) | Specific (Tracks 1&3) | B | M | PW | CW | Color | Power | Combined
(Specify) [1] | Other
(Specify) [2][3] | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal Imaging
and Other | Fetal | N | N | N | N | N | N | Note 1 | Note 2,4 | |
| | Abdominal | N | N | N | N | N | N | Note 1 | Note 2,4 | |
| | Intra-operative (Specify) | | | | | | | | | |
| | Intra-operative (Neurological) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | | | | | | | | | |
| | Small Organ (Specify) * | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card) | | | | | | | | | |
| | Musculo-skeletal (Conventional) | | | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| | Other (Ob/GYN) | N | N | N | N | N | N | Note 1 | Note 2,4 | |
| Cardiac | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| | Other (Specify) | | | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | | | | | | | | | |
| | Other (Urology) | | | | | | | | | |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M
Note 1: Other Combined includes: B/M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonics, The feature does not use contrast agents
Note 3: TDI Note 4: 3D Note 5: 4D
Note 6: Small Organ breast, thyroid, testes
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
{14}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form P11 Portable with L743 Curved Array Transducer
| | Clinical Application | Mode of Operation | | | | | | | | |
|----------------------------|--------------------------------|-------------------|---|----|----|-------|-------|---------------------------|---------------------------|--|
| General (Track 1
only) | Specific (Tracks 1&3) | B | M | PW | CW | Color | Power | Combined
(Specify) [1] | Other
(Specify) [2][3] | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal Imaging
and Other | Fetal | | | | | | | | | |
| | Abdominal | | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | | |
| | Intra-operative (Neurological) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | | | | | | | | | |
| | Small Organ (Specify) * | N | N | N | N | N | N | Note 1 | Note 2,4 | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | | |
| | Musculo-skeletal(Conventional) | N | N | N | N | N | N | Note 1 | Note 2,4 | |
| | Musculo-skeletal (Superficial) | N | N | N | N | N | N | Note 1 | Note 2,4 | |
| | Intravascular | | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| | Other (Specify) | N | N | N | N | N | N | Note 1 | Note 2,4 | |
| Peripheral
Vessel | Peripheral vessel | | | | | | | | | |
| | Other (Urology) | | | | | | | | | |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M
Note 1: Other Combined includes: B/M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonics, The feature does not use contrast agents
Note 3: TDI Note 4: 3D Note 5: 4D
Note 6: Small Organ breast, thyroid, testes
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
{15}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form P11 Portable with L741 Linear Array Transducer
| Clinical Application | | Mode of Operation | | | | | | | |
|----------------------------|-----------------------------------------|-------------------|---|----|----|-------|-------|---------------------------|---------------------------|
| General (Track 1
only) | Specific (Tracks 1&3) | B | M | PW | CW | Color | Power | Combined
(Specify) [1] | Other
(Specify) [2][3] |
| Ophthalmic | Ophthalmic | | | | | | |…
---
**Source:** [https://fda-staging.innolitics.com/device/K170078](https://fda-staging.innolitics.com/device/K170078)
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**Cite:** Innolitics at https://innolitics.com