UltraVision 2 Diagnostic Ultrasound System
Device Facts
| Record ID | K173265 |
|---|---|
| Device Name | UltraVision 2 Diagnostic Ultrasound System |
| Applicant | Winprobe Corporation |
| Product Code | IYN · Radiology |
| Decision Date | Nov 7, 2017 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | 3rd-Party Reviewed |
Indications for Use
This diagnostic ultrasound system (UltraVision) and its transducers are intended for use in clinical examinations to evaluate differences in the echogenicity of soft tissue of small parts in adult patients, (thyroid, breast, and testicles) and for peripheral vessel, abdominal, and superficial muscular skeletal diagnosis. The system is for prescription use only by a trained sonographer under the direction of a qualified physician or directly by a qualified physician.
Device Story
UltraVision 2 is a portable diagnostic ultrasound system; utilizes hand-held linear transducers to transmit ultrasonic energy into patients; processes received echoes to generate real-time anatomical images on a 15-inch high-resolution LCD display. Operates in B-mode, M-mode, Color Flow Doppler, Pulsed Wave (PW) Doppler, and E-mode (elastography). Used in clinical settings by trained sonographers or physicians; facilitates workflow from image acquisition to archival via DICOM interface to PACS. Provides clinicians with visual anatomical data and measurement tools for soft tissue evaluation; aids in clinical diagnosis and patient communication. Benefits include non-invasive, real-time visualization of internal structures.
Clinical Evidence
No clinical data. Substantial equivalence is supported by bench testing, including electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), diagnostic ultrasound safety (IEC 60601-2-37), acoustic output measurement (AIUM/NEMA UD-2), and biocompatibility (ISO 10993).
Technological Characteristics
Portable ultrasound system; 15-inch LCD display (2800x1800 pixels); linear transducers (5-15 MHz). Modes: B, M, Color Flow, PW Doppler, E-mode. Connectivity: DICOM. Power: 90-264V AC. Safety: Class II, Type BF, IP41 (main unit), IPX8 (transducer). Standards: IEC 60601-1, IEC 60601-2-37, ISO 10993. Sterilization: Chemical disinfection (Ortho-Phthalaldehyde/Glutaraldehyde).
Indications for Use
Indicated for adult patients requiring diagnostic ultrasound evaluation of soft tissue echogenicity in small parts (thyroid, breast, testicles), peripheral vessels, abdomen, and superficial musculoskeletal structures.
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
- Siemens Acuson S2000 Ultrasound System (K142876)
Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human profiles facing right, stacked on top of each other. The graphic is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 7, 2017
WinProbe Corporation % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street, NW BUFFALO MN 55313
Re: K173265
Trade/Device Name: UltraVision 2 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: October 25, 2017 Received: October 26, 2017
Dear Mr. Job:
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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
#### Indications for Use
510(k) Number (if known) K173265
#### Device Name
UltraVision 2 Diagnostic Ultrasound System
#### Indications for Use (Describe)
This diagnostic ultrasound system (UltraVision) and its transducers are intended for use in clinical examinations to evaluate differences in the echogenicity of soft tissue of small parts in adult patients, (thyroid, breast, and tor peripheral vessel, abdominal, and superficial muscular skeletal diagnosis.
The system is for prescription use only by a trained sonographer under the direction of a qualified physician or directly by a qualified physician.
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)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
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#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
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FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740 FF
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# Indications for Use Table (system)
#### System: UltraVision 2 Diagnostic Ultrasound System
| Clinical Application | | Mode of Operation | | | | | | Combined<br>(specify) | Other |
|---------------------------|--------------------------------------------------|-------------------|---|-----|-----|------------------|----------------------------------------------------------|-----------------------|-------|
| | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | | | |
| General<br>(Track 1 only) | | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | | | | | | | | |
| | Abdominal | N | N | N | | N | N(B+M), N(B+Color),<br>N (B+E), N(B+PW)<br>N(B+PW+color) | N¹ | |
| | Intra-operative (specify) | | | | | | | | |
| | Intra-operative (neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (specify)<br>Breast, Thyroid, Testes | P | N | N | | N | N(B+M), N(B+Color),<br>N (B+E), N(B+PW)<br>N(B+PW+color) | N¹ | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-cardiac) | | | | | | | | |
| | Musculo-skeletal (conventional) | | | | | | | | |
| | Musculo-skeletal (superficial) | P | N | N | | N | N(B+M), N(B+Color),<br>N (B+E), N(B+PW)<br>N(B+PW+color) | N¹ | |
| | Intravascular | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | N | N | N | | N | N(B+M), N(B+Color)<br>N (B+E), N(B+PW)<br>N(B+PW+color) | N¹ | |
| | Other (specify) | | | | | | | | |
N = new indication; P= previously cleared by FDA 510(k)150580. Notes: ¹Elastography (E-Mode)
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# Indications for Use Table (transducer)
## Transducer: HL5-10EPN transducer for use with UltraVision 2
| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|--------------------------------------------------|-------------------|---|-----|-----|------------------|----------------------------------------------------------|-------|
| General | Specific | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(specify) | Other |
| (Track 1 only) | (Tracks 1 & 3) | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | | | | | | | |
| | Abdominal | N | N | N | | N | N(B+M), N(B+Color),<br>N (B+E), N(B+PW)<br>N(B+PW+color) | N¹ |
| | Intra-operative (specify) | | | | | | | |
| | Intra-operative (neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (specify)<br>Breast, Thyroid, Testes | P | N | N | | N | N(B+M), N(B+Color),<br>N (B+E), N(B+PW)<br>N(B+PW+color) | N¹ |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-cardiac) | | | | | | | |
| | Musculo-skeletal (conventional) | | | | | | | |
| | Musculo-skeletal (superficial) | P | N | N | | N | N(B+M), N(B+Color),<br>N (B+E), N(B+PW)<br>N(B+PW+color) | N¹ |
| | Intravascular | | | | | | | |
| | Other (specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (specify) | | | | | | | |
| Peripheral Vessel | Peripheral vessel | N | N | N | | N | N(B+M), N(B+Color)<br>N (B+E), N(B+PW)<br>N(B+PW+color) | N¹ |
| | Other (specify) | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | |
| General<br>(Track 1 only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(specify) | Other |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | | | | | | | |
| | Abdominal | N | N | N | | N | N(B+M), N(B+Color),<br>N (B+E), N(B+PW)<br>N(B+PW+color) | N1 |
| | Intra-operative (specify) | | | | | | | |
| | Intra-operative (neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (specify)<br>Breast, Thyroid, Testes | N | N | N | | N | N(B+M), N(B+Color),<br>N (B+E), N(B+PW)<br>N(B+PW+color) | N1 |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-cardiac) | | | | | | | |
| | Musculo-skeletal (conventional) | | | | | | | |
| | Musculo-skeletal (superficial) | N | N | N | | N | N(B+M), N(B+Color),<br>N (B+E), N(B+PW)<br>N(B+PW+color) | N1 |
| | Intravascular | | | | | | | |
| | Other (specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (specify) | | | | | | | |
| Peripheral Vessel | Peripheral vessel | N | N | N | | N | N(B+M), N(B+Color)<br>N (B+E), N(B+PW)<br>N(B+PW+color) | N1 |
| | Other (specify) | | | | | | | |
N = new indication; P= previously cleared by FDA 510(k) 150580 Notes: ¹Elastography (E-Mode)
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# Indications for Use Table (transducer)
## Transducer: L14-4 transducer for use with UltraVision 2
N = new indication; Notes: ¹Elastography (E-Mode)
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# 510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
The assigned 510(k) number is:
#### Submitter
WinProbe Corporation 11770 US Highway 1, suite 302E Palm Beach Gardens, Florida 33408 Telephone: (561)626-4055 Fax: (561)624-0914 Registration #
### Official Correspondent:
Guy Scott WinProbe Corp. President Email: gscott@winprobe.com Telephone: (561)626-4055 11662 Lake Shore Place North Palm Beach, Florida 33408
Or
Rose Malchow WinProbe Corp. Quality Manager Email: rmalchow@winprobe.com Telephone: (561)626-4055 11770 US Highway 1, suite 302E Palm Beach Gardens, Florida 33408
### Date Prepared:
September 28th, 2017
### Device Name and Classification:
Common/Usual Name:
Diagnostic Ultrasound System
Proprietary Name:
UltraVision 2 Diagnostic Ultrasound System
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Image /page/7/Picture/0 description: The image is a coat of arms featuring a red griffin holding a spear on a white background. A banner with the word "imagine" is draped over the spear. The griffin is depicted in a dynamic pose, with one paw raised and wings spread. The shield shape is a classic heraldic form with a curved base.
| Classification Names: | FR Number | Product Code | | UltraVision 2 | Acuson S2000 | UltraVision 2 (as cleared |
|------------------------------------------|-----------|--------------|--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Ultrasound Pulsed Echo Imaging System | 892.1560 | IYO | | | | by k150580) |
| Diagnostic Ultrasound Transducer | 892.1570 | ITX | Description | The UltraVision is a<br>portable Diagnostic<br>Ultrasound System, which<br>applies the latest<br>technologies to produce<br>optimal images. The<br>system facilitates a<br>workflow from image<br>acquisition through to<br>archival in a standard<br>DICOM interface to the<br>clinics PACs system.<br>Various image parameter<br>adjustments, a 15 inch<br>high resolution display and<br>custom probes are<br>configured to provide clear<br>and stable images. It<br>operates in B, M, Color<br>Flow Doppler, PW Doppler<br>Mode, and E mode. | The ultrasound systems are<br>multi-purpose mobile,<br>software controlled<br>diagnostic ultrasound<br>systems with and on-screen<br>display for thermal and<br>mechanical indices related to<br>potential bio-effect<br>mechanisms. The function is<br>to acquire primary or<br>secondary harmonic<br>ultrasound echo data and<br>display it in B-Mode, M-<br>Mode, Pulsed (PW) Doppler<br>Mode, Continuous (CW)<br>Doppler Mode, Color Doppler<br>Mode, Amplitude, Doppler<br>Mode, a combination of<br>modes, or Harmonic Imaging<br>and 3D/4D Imaging on a Flat<br>Panel Display. | The UltraVision is a<br>portable Diagnostic<br>Ultrasound System, which<br>applies the latest<br>technologies to produce<br>optimal images. The<br>system facilitates a<br>workflow from image<br>acquisition through to<br>archival in a standard<br>DICOM interface to the<br>clinics PACs system.<br>Various image parameter<br>adjustments, a 15 inch<br>high resolution display and<br>custom probes are<br>configured to provide clear<br>and stable images. It<br>operates in B mode. |
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | IYN | Intended Use | This diagnostic ultrasound<br>system (UltraVision) and<br>its<br>transducers are<br>intended for use in clinical<br>examinations to evaluate<br>differences in the<br>echogenicity of soft tissue<br>of small parts in adult<br>patients, (thyroid, breast,<br>and testicles) and for<br>peripheral vessel,<br>abdominal, and superficial<br>muscular skeletal<br>diagnosis. | The ultrasound imaging<br>systems are intended for the<br>following applications: Fetal,<br>Abdominal, Intraoperative,<br>Pediatric, Small Parts,<br>Transcranial, OB/GYN,<br>Cardiac, Pelvic,<br>Neonatal/Adult Cephalic,<br>Vascular, Musculoskeletal,<br>Superficial Musculoskeletal,<br>and Peripheral Vascular<br>applications.The system also<br>provides the ability to<br>measure anatomical<br>structures {fetal, abdominal,<br>intraoperative, pediatric,<br>small organ, neonatal<br>cephalic, adult cephalic, | This diagnostic ultrasound<br>system (UltraVision) and<br>its transducers are<br>intended for use in clinical<br>examinations to evaluate<br>differences in the<br>echogenicity of soft tissue<br>of small parts in adult<br>patients, (thyroid, breast,<br>and testicles) and for<br>superficial muscular<br>skeletal diagnosis. |
# Predicate Device:
Siemens Acuson S2000 Ultrasound System, K142876
## Device Description:
The UltraVision 2 is a portable Diagnostic Ultrasound System which applies the latest technologies to produce optimal images. Various image parameter adjustments, a 15 inch high resolution display, and custom probes are configured to provide clear and stable images. It operates in B-mode, M-Mode, Color Flow Doppler Mode, Pulsed Wave Doppler Mode, and E-Mode.
## Intended Use:
This diagnostic ultrasound system (UltraVision) and its transducers are intended for use in clinical examinations to evaluate differences in the echogenicity of soft tissue of small parts in adult patients, (thyroid, breast, and testicles) and for peripheral vessel, abdominal, and superficial muscular skeletal diagnosis.
The system is for prescription use only by a trained sonographer under the direction of a qualified physician or directly by a qualified physician.
### Comparison to the predicate device:
The UltraVision 2 diagnostic ultrasound system uses the same fundamental scientific technologies as the predicate device (Siemens Acuson S2000, K142876). Table 1 compares the UltraVision 2 to the predicate device with respect to indications for use, intended use, and principles of operation for the determination of substantial equivalence. The table also compares the system to the previously cleared system.
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Image /page/9/Picture/0 description: The image shows a coat of arms with a red griffin holding a spear. The griffin is standing on its hind legs and has wings. A banner with the word ".IMAGINE." is draped over the spear. The coat of arms has a white background and a black border.
| | cardiac, trans-esophageal, | |
|--|--------------------------------|--|
| | transrectal, transvaginal, | |
| | peripheral vessel, musculo- | |
| | skeletal (conventional), | |
| | musculo-skeletal (superficial) | |
| | and neonatal cardiac} and | |
| | calculation packages that | |
| | provide information to the | |
| | clinician that may be used | |
| | adjunctively with other | |
| | medical data obtained by a | |
| | physician for clinical | |
| | diagnosis purposes. The | |
| | Arterial Health Package | |
| | (AHP) software provides the | |
| | physician with the capability | |
| | to measure Intima Media | |
| | Thickness and the option to | |
| | reference normative tables | |
| | that have been validated and | |
| | published in peer-reviewed | |
| | studies. The information is | |
| | intended to provide the | |
| | physician with an easily | |
| | understood tool for | |
| | communicating with patients | |
| | regarding state of their | |
| | cardiovascular system. This | |
| | feature should be utilized | |
| | according to the "ASE | |
| | Consensus Statement; Use | |
| | of Carotid Ultrasound to | |
| | Identify Subclinical Vascular | |
| | Disease and Evaluate | |
| | Cardiovascular Disease Risk: | |
| | A Consensus Statement from | |
| | the American Association of | |
| | Echocardiography; Carotid | |
| | Intima-Media Thickness Task | |
| | Force, Endorsed by the | |
| | Society for Vascular | |
| | Imaging". The Acuson | |
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Image /page/10/Picture/0 description: The image is a coat of arms with a white background and a black border. In the center of the coat of arms is a red griffin holding a spear. Above the griffin is a red banner with the word "imagine" written on it.
| | | Acunav Ultrasound Catheter<br>is intended for intra-cardiac<br>and intra-luminal visualization<br>of cardiac and great vessel<br>anatomy and physiology, as<br>well as visualization of other<br>devices in the heart of adult<br>and pediatric patients | |
|------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Power Supply | | | |
| Voltage | 90-264 V AC | 90-264 V AC | 90-264 V AC |
| Frequency | 50/60 Hz | 50/60 Hz | 50/60 Hz |
| Operation<br>Characteristic | | | |
| Installation and<br>use | a. Portable equipment<br>b. Mobile equipment<br>(when installed on<br>the mobile cart) | Mobile equipment | a. Portable<br>equipment<br>b. Mobile<br>equipment<br>(when<br>installed on<br>the mobile<br>cart) |
| Mode of operation | Continuous operation | Continuous operation | Continuous operation |
| Physical<br>Specifications | | | |
| Dimensions | 400 mm (W) x 50 mm (H) x<br>250 mm (D) | 623 mm (W) x 1300 mm<br>(H) x 1103 mm (D) | 400 mm (W) x 50 mm<br>(H) x 240 mm (D) |
| Weight | 4.5 kg | 166 kg | 4.5 kg |
| Temperature | | | |
| Operating: | 0°C to 40°C | 10°C to 40°C | 0°C to 40°C |
| Transport/Storage: | Equipment should not be<br>subject to excessive<br>temperatures during<br>transportation/storage | -20°C to 60°C | Equipment should not<br>be subject to<br>excessive<br>temperatures during |
| | | | transportation/storage |
| Relative Humidity | | | |
| Operating: | Equipment should not be<br>used in locations of high<br>humidity | 10% to 80% | Equipment should not<br>be used in locations<br>of high humidity |
| Transport/Storage: | Equipment should not be<br>used in locations of high<br>humidity | 10% to 95% | Equipment should not<br>be used in locations<br>of high humidity |
| Safety<br>Classifications | | | |
| Type of protection<br>against electric<br>shock | Class II | Class I | Class II |
| The degree of<br>protection against<br>electric shock | Type BF | Type BF | Type BF |
| The degree of<br>protection against<br>the harmful<br>ingress of liquid | IP41 for the main unit<br>IPX8 for the transducer | Ordinary equipment<br>IPX8 for the transducers | IP41 for the main unit<br>IPX8 for the<br>transducer |
| The degree of<br>safety of<br>application in the<br>presence of a<br>flammable gas | Equipment not to be used in<br>the presence of a flammable<br>gas | Equipment not to be used<br>in the presence of a<br>flammable gas | Equipment not to be<br>used in the presence<br>of a flammable gas |
| Electrical &<br>Mechanical Safety<br>& Thermal Safety<br>Standards | | | |
| The electrical,<br>mechanical, and<br>thermal safety<br>evaluation | Complies with the standard:<br>IEC 60601-1: 2007<br>IEC 60601-2-37: 2008 | Complies with the standard:<br>IEC 60601-1: 2007<br>IEC 60601-2-37: 2008 | Complies with the<br>standard:<br>IEC 60601-1: 2007<br>IEC 60601-2-37:<br>2008 |
| EMC evaluation | Complies with the standard:<br>IEC 60601-1-2 4th edition | Complies with the standard:<br>IEC 60601-1-2 | Complies with the<br>standard: IEC<br>60601-1-2 3rd edition |
| Acoustic output<br>evaluation | Complies with the standard:<br>IEC 61157 AIUM/NUMA UD-2, Acoustic Output<br>Measurement Standard for<br>Diagnostic Ultrasound | Complies with the standard:<br>IEC 61157 AIUM/NUMA<br>UD-2, Acoustic Output<br>Measurement Standard for<br>Diagnostic Ultrasound | Complies with the<br>standard:<br>IEC<br>61157 AIUM/NUMA<br>UD-2, Acoustic<br>Output Measurement<br>Standard for<br>Diagnostic<br>Ultrasound |
| Biocompatibility<br>evaluation | Complies with the standard:<br>ISO 10993-1: 2009<br>ISO 10993-5: 2009<br>ISO 10993-10: 2009 | Complies with the standard:<br>ISO 10993-1: 2009<br>ISO 10993-5: 2009<br>ISO 10993-10: 2009 | Complies with the<br>standard:<br>ISO 10993-1: 2009<br>ISO 10993-5: 2009<br>ISO 10993-10: 2009 |
| Disinfection | | | |
| Disinfection | Probe: .55% Ortho<br>Phthalaldehyde, 2.4%<br>Glutaraldehyde | Probe: .55% Ortho-<br>Phthalaldehyde 2.4%<br>Glutaraldehyde | Probe: .55% Ortho<br>Phthalaldehyde, 2.4%<br>Glutaraldehyde |
| Specifications | | | |
| Monitor | 15 inch display LCD flat<br>panel display with 2800 x<br>1800 pixels | 19 inch high-resolution flat<br>panel display | 15 inch display LCD<br>flat panel display with<br>2800 x 1800 pixels |
| General imaging<br>mode | B mode, M mode, E mode,<br>Color flow dopper mode,<br>shear mode | B mode, M mode, PWD<br>mode, Color mode, CWD<br>mode, eSie TouchTM<br>Virtual TouchTM | B mode |
| Scanning method | Linear | Linear, Rocked, Auto-<br>sweep, STIC (Spatial<br>Temporal Imaging<br>Correlation) | Linear |
| Focus number | Max=4 | | Max=4 |
| B mode general | Distance | Distance/Depth, Volume | Distance |
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Image /page/11/Picture/0 description: The image is a coat of arms with a white background and a black border. In the center of the coat of arms is a red winged lion holding a spear. Above the lion is a red banner with the word "Imagine" written on it.
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Image /page/13/Picture/0 description: The image shows a coat of arms with a white background and a black border. In the center of the coat of arms is a red griffin holding a spear. Above the griffin is a red banner with the word "imagine" written on it.
| measurements<br>M mode general<br>measurements | Distance, Time | and Stenosis, Area,<br>Volume Flow,<br>Circumference<br>Distance, Heart Rate,<br>Slope, Time | / |
|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|
| D mode general<br>measurements | 1 | Measurements on a frozen<br>or CINE image including<br>velocity/frequency, HR<br>(Heart Rate), S/D<br>(systolic/diastolic) ratio, RI<br>(resistive index), PI<br>(pulsatility index), TAMx<br>(time-average maximum),<br>TAMn (time-average<br>mean), Slope<br>(acceleration/deceleration),<br>volume flow, A/B ratios,<br>Time | |
| Color Flow<br>Doppler Mode<br>general<br>measurements | Distance | Measurements on a frozen<br>or CINE image including<br>velocity/frequency, HR<br>(heart rate), S/D<br>(systolic/diastolic ratio), RI<br>(resistive index), PI<br>(pulsatility index), TAMx<br>(time-average maximum),<br>TAMn (time-average<br>mean), Slope<br>(Acceleration/Deceleration),<br>Volume Flow, A/B ratios,<br>Time | |
| PW Doppler Mode<br>general<br>measurements | Velocity | Measurements on a frozen<br>or CINE image including<br>velocity/frequency, HR<br>(heart rate), S/D<br>(systolic/diastolic ratio), RI<br>(resistive index), PI<br>(pulsatility index), TAMx<br>(time-average maximum), | |
| | | TAMn (time-average mean), Slope (Acceleration/Deceleration), Volume Flow, A/B ratios, Time | |
| E Mode/eSie<br>Touch™ general<br>measurements | Provides a qualitative<br>representation of relative<br>tissue stiffness for the region<br>of interest | Provides a qualitative<br>representation of relative<br>tissue stiffness for the<br>region of interest | / |
| Shear<br>Mode/Virtual<br>Touch™ Mode<br>general<br>measurements | / | Use Virtual Touch tissue<br>quantification to measure<br>tissue shear velocity (Vs)<br>for a selected region of<br>interest. Virtual Touch<br>quantification uses acoustic<br>radiation force impulse<br>(ARFI) technology of<br>diagnostic ultrasound to<br>induce tissue displacement.<br>A time-controlled sequence<br>of "push pulses" from the<br>transducer induces a small<br>displacement of tissue. The<br>ultrasound system<br>measures shear wave<br>velocity at the region of<br>interest | / |
| Peripheral<br>Devices<br>Supported | | | |
| Printer | Sony type UPD25MD (USB)<br>color video printer | Black and white Mitsubishi<br>printer P-93DW, color Sony<br>printer UP-D23MD | Sony type UPD25MD<br>(USB) color video<br>printer |
| Performance | | | |
| Displayed depth | 20 mm to 300 mm | .5 cm to 30 cm | 20 mm to 300 mm |
| Gray scales | 256 | 256 | 256 |
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Image /page/14/Picture/0 description: The image is a coat of arms featuring a red griffin holding a spear on a white background. A banner with the word "Imagine" is draped around the spear. The coat of arms has a black border. The griffin is depicted in a dynamic pose, suggesting movement and strength.
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Image /page/15/Picture/0 description: The image is a coat of arms featuring a red griffin holding a spear on a white background. Above the griffin is a banner with the word "imagine" written on it. The shield has a black border. The griffin is depicted in a dynamic pose, with its wings spread and one leg raised.
| TGC | 8 segments | | 8 segments | |
|-------------------------------|-----------------------------|---------------------------------------------------|------------|--------|
| Image<br>Adjustments | | | | |
| B mode<br>parameters | Gain | Gain | Gain | |
| | Depth | Gray scale map | Depth | |
| | TGC | SieClear spatial<br>compounding | TGC | |
| | Frequency | Edge enhancement | Frequency | |
| | / | Tint/balance | / | |
| | / | Level of clarify vascular<br>enhancement | / | |
| | / | Gray scale or color map for<br>elasticity imaging | / | |
| | | | | |
| M mode<br>parameters | Gain | Gain | / | |
| | Map | Map | / | |
| | / | Tint | / | |
| | Transmit Frequency | Transmit frequency | / | |
| | | | | |
| Color mode &<br>Power Doppler | Transmit Frequency | Transmit frequency | / | |
| mode &<br>Directional Power | Gain | Gain | / | |
| mode parameters | Persistence | Persistence | / | |
| | Pulsed repetition frequency | Pulsed repetition frequency | / | |
| | Smoothing | Smoothing | / | |
| | Map | Map | / | |
| | | | | |
| Measurement<br>Accuracy | | | | |
| 2D Measurement | | | | |
| Depth/Distance | Range | 400 mm | 34 cm | 400 mm |
| | Accuracy | 5% | 5% | 5% |
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Image /page/16/Picture/0 description: The image is a coat of arms featuring a red griffin holding a spear on a white background. The griffin is standing upright and facing left, with its wings spread. A banner with the word "imagine" is draped above the griffin. The shield has a black border.
Table 1. Predicate Device Comparison
Intended Use:
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The intended use and clinical applications of the UltraVision 2 system are narrowed, but still in the scope of the predicate device. Both systems are intended to be used with a conventional extracorporeal transducer. The type of transducers specified for use with the UltraVision 2 system are both linear which is also used with the predicate system. A comparison of the transducers is provided in Table 2:
| | HL5-10EPN | L14-4 | 14L5 |
|-------------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Type | Linear | Linear | Linear |
| Frequency Bandwidth | 5 - 12 MHz | 5-15 MHz | 5 - 14 MHz |
| Applications | • Breast<br>• Testes<br>• Thyroid<br>• Musculoskeletal<br>• Peripheral Vessel<br>• Abdominal | • Breast<br>• Testes<br>• Thyroid<br>• Musculoskeletal<br>• Peripheral Vessel<br>• Abdominal | • Breast<br>• Testes<br>• Thyroid<br>• Musculoskeletal<br>• Peripheral Vessel<br>• Abdominal |
| Number of Elements | 128 | 256 | 128 |
| Modes of Operation | B, E, M,<br>CFD,PWD | B, E, M, CFD,<br>PWD | B, C, D, M |
| Array Footprint | 38.1 mm | 52 mm | 39 mm |
| Acoustic output display<br>standard | Track 1 | Track 1 | Track 3 |
| Mechanical Index (MI) | .164 | .82 | 1.1 |
| ISPTA (mW/cm²) | 83 | 75 | 114 |
| Maximum Power (mW) | .35…
