MYLABSIX ULTRASOUND SYSTEM
Device Facts
| Record ID | K141486 |
|---|---|
| Device Name | MYLABSIX ULTRASOUND SYSTEM |
| Applicant | Esaote Europe B.V. |
| Product Code | IYN · Radiology |
| Decision Date | Jul 11, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Indications for Use
Esaote's MyLabSix ultrasound system is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative Abdominal, and Other: Urologic. The system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.
Device Story
MyLabSix is a mainframe ultrasound system for diagnostic general ultrasound studies. It processes signals from phased, convex, linear array, Doppler, and volumetric probes. Operating modes include B-Mode, Amplitude Doppler (AD), Tissue Enhancement Imaging (TEI), XView, Multi View (MView), Trapezoidal View (TP View), Tissue Velocity Mapping (TVM), RF-based Quality Intima Media Thickness (QIMT), Color Flow Mapping (CFM), and Pulse Wave Doppler. The system features a main LCD display and an integrated touch-screen control panel. Data is stored on internal hard disks, DVD-RW, or external media via LAN/USB. Used in clinical settings by healthcare professionals, the device provides real-time imaging to assist in biopsy, needle placement, and peripheral nerve blocks, aiding clinical diagnosis and procedural guidance.
Clinical Evidence
No clinical tests were performed. Substantial equivalence is supported by non-clinical bench testing, including acoustic output, biocompatibility, cleaning/disinfection, thermal, electromagnetic, and mechanical safety testing.
Technological Characteristics
Mainframe ultrasound system with phased, convex, linear, Doppler, and volumetric probes. Features LCD display with integrated touch-screen control panel. Connectivity via LAN/USB. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD-2, and NEMA UD-3. Software includes measurement and analysis packages. Sterilization/disinfection per manufacturer instructions.
Indications for Use
Indicated for diagnostic ultrasound imaging and fluid flow analysis in adult and pediatric patients for cardiac, vascular, abdominal, fetal, small organ, musculoskeletal, and urologic applications, including biopsy and needle guidance.
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
Submission Summary (Full Text)
{0}------------------------------------------------
JUL 1 1 2014
K141486
page 1 of 4
### 510(k) Summary MyLabSix Esaote Europe
# 510(k) Summary
The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 1807.92(a).
807.92(a)(1)
## Submitter Information
Esaote Europe B.V. Philipsweg I 6227 AJ Maastricht The Netherlands
Contact Person: Allison Scott, RAC 317.228.8719 Office 317.372.0276 Mobile allison.scott@navigant.com
Date:
January 20, 2014
807.92(a)(2)
| Trade Name: | MyLabSix Ultrasound System | |
|-------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------|
| Common Name: | Ultrasound Imaging System | |
| Classification Name(s): | Ultrasonic pulse Doppler imaging system<br>Ultrasonic pulsed echo imaging system<br>Diagnostic ultrasonic transducer | 892.1550<br>892.1560<br>892.1570 |
| Classification Number: | 90IYN, 90IYO, 90ITX | |
{1}------------------------------------------------
510(k) Summary MyLabSix Esaote Europe
### 807.92(a)(3)
### Predicate Device(s)
| K111302, K132231 and K132466 | MyLabSeven | Esaote SpA |
|------------------------------|------------|--------------------|
| K083882 | MyLabFive | Esaote Europe B.V. |
Additional substantial equivalence information is provided in the following substantial equivalence comparison table.
### Device Description
The MyLabSix is a mainframe ultrasound system used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, Amplitude Doppler (AD), Tissue Enhancement Imaging (TEI), XView, Multi View (MView). Trapezoidal View (TP View), Tissue Velocity Mapping (TVM), RF-based Quality Intima Media Thickness (QIMT) ,Color Flow Mapping (CFM) and Pulse Wave Doppler.
The MyLabSix is equipped with a free orientable LCD Color Display were acquired images and advanced images are shown.
A second LCD Display for additional controls and mode-depending keys, includes touch screen technology and is integrated in the control panel.
The MyLabSix can drive phased (PA), convex (CA), linear array (LA) probes, Doppler probes and Volumetric probes.
The MyLabSix is equipped with an internal Hard Disk and with an DVD-RW disk drive that can be used for image storage. Data can also be stored directly to external archiving media (Hard-Disk, PC, server) via a LAN/USB port.
The MyLabSix is manufactured under an ISO 9001:2008 and ISO 13485:2003 certified quality system.
{2}------------------------------------------------
510(k) Summary MyLabSix Esaote Europe
### 807.92(a)(5)
## Intended Use(s)
Esaote's MyLabSix ultrasound system is a mainframe ultrasound svstem used to perform diagnostic general ultrasound studies including Cardiac. Transesophageal Cardiac. Peripheral Vascular. Neonatal Cephalic. Adult Cephalic. Small Organs. Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative Abdominal, and Other: Urologic. The system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.
### 807.92(a)(6)
### Technological Characteristics
Esaote Europe B.V. believes that the MyLabSix is substantial equivalent to Esaote's MyLabSeven product (K111302. K132231 and K132466) and Esaote's MyLabFive (K083882).
- · Clinical uses for which the MyLabSix is designed are equivalent to those cleared for Esaote's MyLabSeven and MyLabFive .
- .
- · The MyLabSix, Esaote's MyLabSeven and Esaote's MyLabFive are designed to meet the IEC60601-1 and the IEC60601-2-37 safety requirements.
- · The MyLabSix, Esaote's MyLabSeven and Esaote's MvLabFive provides an Acoustic Output Display feature per AIUM / NEMA standards. with equivalent Ispta and MI maximal values.
- · The MyLabSix, Esaote's MyLabSeven and Esaote's MyLabFive provides a similar measurements and analysis package, with equal accuracy and precision.
- · The MyLabSix, Esaote's MyLabSeven and Esaote's MyLabFive have a digital storage capabilities, including Network connectivity.
- · The MyLabSix image modes are available on other FDA cleared ultrasound systems. for instance Esaote's MyLabSeven and Esaote's MyLabFive.
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K141486
Page 4 of 4
510(k) Summary MyLabSix Esaote Europe 807.92(b)(1)
# Summary of Non-Clinical Tests
The MyLabSix has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electromagnetic. and mechanical safety, and have been found to conform to the following medical device safety standards.
- · IEC 60601-1
- · IEC 60601-1-2
- · IEC 60601-2-37
- · NEMA UD-3 Standard for Real time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- · NEMA UD-2 Acoustic Output Measurement Standard for Diagnostic Ultrasound
### 807.92(b)(2)
### Summary of Clinical Tests
No clinical tests were performed.
### 807.92(b)(3)
### Conclusion
The MyLabSix is substantially equivalent to the legally marketed devices and conform to applicable medical device safety and performance standards.
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure with three arms or lines extending from the body.
### DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 11, 2014
Esaote Europe B.V. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Rc: K141486
Trade/Device Name: MyLabSix Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN. IYO. ITX Dated: June 5, 2014 Received: June 9, 2014
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.
This determination of substantial equivalence applies to the following transducers intended for use with the MyLabSix Ultrasound System, as described in your premarket notification:
| | Transducer Model Number | |
|--------|-------------------------|--------|
| AC2541 | SC3421 | SC3123 |
| SE3123 | AL2442 | SL3332 |
| SL1543 | SL3323 | SL3235 |
| SP2730 | S2MCW | S5MCW |
| SHFCW | SB2C41 | ST2612 |
| IOT342 | | |
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
{5}------------------------------------------------
Page 2-Mr. Job
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) (2) 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.
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/ResourcesforYou/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. O'Hara for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
### Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
### 510{k} Number (if known)
### K 141486
Device Name MyLabSix Ultrasound System
### Indications for Use (Describe)
Esaote's MyLabSix ultrasound system is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiae, Peripheral Vascular. Neonatal Cephalic. Adult Cephalic. Small Organs, Musculoskelcial (Conventional and Superficial), Abdominal, I'etal, Transvaginal, Transrectal, Pediatric, Intraoperative Abdominal, and Other: Urologic. The system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.
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)
### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
### FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Michael D. O'Hara
FORM FDA 3881 (9/13) Esaote Europe B.V.
Page 1 of 19 MyLabSix Ultrasound System (301) 443-6740
Page 6
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| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (AD) | Combined [4] | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) |
|-----------------------------------|---|---|-----|-----|---------------|------------------------|--------------|------------------------------|------------------------|-----------------|
| Ophthalmic | N | N | N | N | N | N | N | N | N | 5,7 |
| Fetal | N | N | N | N | N | N | N | N | N | 5,7 |
| Abdominal | N | N | N | N | N | N | N | N | N | S |
| Intraoperative (Abdominal) | N | N | N | N | N | N | N | N | N | S |
| Intraoperative Neurological | N | N | N | N | N | N | N | N | N | S |
| Pediatric | N | N | N | N | N | N | N | N | N | S |
| Small Organs [1] | N | N | N | N | N | N | N | N | N | S |
| Neonatal Cephalic | N | N | N | N | N | N | N | N | N | S |
| Adult Cephalic | N | N | N | N | N | N | N | N | N | S |
| Cardiac [2] | N | N | N | N | N | N | N | N | N | S |
| Transesophageal (Cardiac) | N | N | N | N | N | N | N | N | N | S |
| Transesophageal (Non Cardiac) | N | N | N | N | N | N | N | N | N | S |
| Transrectal | N | N | N | N | N | N | N | N | N | S |
| Transvaginal | N | N | N | N | N | N | N | N | N | S |
| Transurethral | N | N | N | N | N | N | N | N | N | S |
| Intravascular | N | N | N | N | N | N | N | N | N | S |
| Peripheral Vascular | N | N | N | N | N | N | N | N | N | S |
| Laparoscopic | N | N | N | N | N | N | N | N | N | S |
| Musculo-skeletal Conventional [3] | N | N | N | N | N | N | N | N | N | S |
| Musculo-skeletal Superficial [3] | N | N | N | N | N | N | N | N | N | S |
| Other (Urological) | N | N | N | N | N | N | N | N | N | S |
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N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
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Prescription Use Only Per 21 CFR 801 Part D
Concurrence of Center for Devices and Radiological Health (CDRH)
{8}------------------------------------------------
| 1 | AC2541 |
|----|--------|
| 2 | SC3421 |
| 3 | SC3123 |
| 4 | SE3123 |
| 5 | AL2442 |
| 6 | SL3332 |
| 7 | SL1543 |
| 8 | SL3323 |
| 9 | SL3235 |
| 10 | SP2730 |
| 11 | S2MCW |
| 12 | S5MCW |
| 13 | SHFCW |
| 14 | SB2C41 |
| 15 | ST2612 |
| 16 | IOT342 |
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{9}------------------------------------------------
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows | | | | | | | | | | |
|---------------------------------------------------------------------------------------------|----|----|-----|-----|----------------|--------------------------|----------------|------------------------------|-------------------------|-----------------|
| | | | | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (AD) | Combined [ ] | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | P | P | P | | P | P | P | | P | S |
| Abdominal | P | P | P | | P | P | P | | P | S |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organs [1] | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | | P | S |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional [3] | P | P | P | | P | P | P | | P | S |
| Musculo-skeletal Superficial (3) | P | P | P | | P | P | | | P | S |
| Other (Urological) | P | P | P | | P | P | P | | P | S |
| | | | | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (AD) | Combined [4] | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify] |
| Ophthalmic | | | | | | | | | | |
| Fetal | P | P | P | | P | P | P | | P | S |
| Abdominal | P | P | P | | P | P | P | | P | S |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | | P | S |
| Small Organs [1] | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | | P | S |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | | P | S |
| Musculo-skeletal Superficial [3] | P | P | P | | P | P | P | | P | S |
| Other (Urological) | P | P | P | | P | P | P | | P | S |
| The SC3421 probe is already | | | | | | | | | | |
| tended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows | | | | | | | | | | |
| | | | | | | ode of Operation | | | | |
| Haical Applicatio | 8 | 2 | PWD | CWD | Öoppk<br>Color | aplikude Doppler (AD) | Combined<br> 4 | Color Velocity Kapping (TVM | maging (TEI<br>larmonic | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| etal | N | N | N | | N | N | N | | 도 | S |
| bdominal | K | L | k | | Al | n | N | | k | S |
| ntraoperative (Abdomina | | | | | | | | | | |
| ntraoperative Neurologic | | | | | | | | | | |
| ediatric | d | c. | ﻟ | | d | d | d | | d | S |
| mail Organs | d | 느 | - | | d | d | d | | ﺎ | 5 |
| ronatal Cephali | d | d | e | | ਹੈ | ﺷ | L | | 시 | 5 |
| dult Cephalic | | | | | | | | | | |
| ardine [2] | la | t | r | | d | t | d | | ﮯ | S |
| tansesophageal (Cardia | | | | | | | | | | |
| ransesophageal (Non Card | | | | | | | | | | |
| ransntcla | | | | | | | | | | |
| ransvagina | | | | | | | | | | |
| ransurethra | | | | | | | | | | |
| ntravascular | | | | | | | | | | |
| cripheral Vascular | 5 | ત | ನ | | d | d | d | | ત | S |
| aparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventio<br>ਲ | ﻄ | n | d | | d | d | d | | ರ್ಥ | 5 |
| Musculo-akcietal Superficial | d | d | ਰ | | a | B. | d | | P | S |
| Other (Urological | | | | | | | | | | |
| The SC3123 probe is alread | | | | | | | | | | |
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{10}------------------------------------------------
ni SC3421
cleared via K101605
N: New indication; P: Previously cleared by FDA; E:Added under App
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{11}------------------------------------------------
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: New indication; P: Previously cleared by FDA; E:Added under Appendix 8
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{12}------------------------------------------------
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows: | | | | | | | | | | | |
|----------------------------------------------------------------------------------------------|---|---|-----|-----|--------------------|------------------------------|-----------------|----------------------------------|---------------------------|-----------------|--|
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler<br>(AD) | Combined<br>(4) | Color Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) | |
| Ophthalmic | | P | | | | | | | | | |
| Fetal | | P | P | | P | P | P | | P | 5 | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organs (1) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac (2) | | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | P | P | P | | P | P | P | | P | 5 | |
| Transvaginal | P | P | P | | P | P | P | | P | 5 | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial (3) | | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | | |
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows: | | | | | | Mode of Operations | | | | | |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler [AD] | Combined [4] | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) | |
| Ophthalmic | | | | | | | | | | | |
| Rectal | P | P | P | | P | P | P | | P | 5 | |
| Abdominal | P | P | P | | P | P | P | | P | 5 | |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | | P | 5 | |
| Small Organs [1] | P | P | P | | P | P | P | | P | 5 | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | P | P | P | | P | P | P | | P | 5 | |
| Transesophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | | P | 5 | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional<br>(3) | P | P | P | | P | P | P | | P | 5 | |
| Musculo-skeletal Superficial [3] | P | P | P | | P | P | P | | P | 5 | |
| Other (Urological) | | | | | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (AD) | Combined [4] | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | N | N | N | N | N | N | N | N | N | 5 | |
| Abdominal | N | N | N | N | N | N | N | N | N | 5 | |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | N | N | N | N | N | N | N | N | N | 5 | |
| Small Organs [1] | N | N | N | N | N | N | N | N | N | 5 | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | N | N | N | N | N | N | N | N | N | 5 | |
| Transesophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | N | N | N | N | N | N | N | N | N | 5 | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional [3] | N | N | N | N | N | N | N | N | N | 5 | |
| Musculo-skeletal Superficial [3] | N | N | N | N | N | N | N | N | N | 5 | |
| Other (Urological) | | | | | | | | | | | |
| The SL-3332 probe is to be | | | | | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler<br>(AD) | Combined<br>(4) | Color Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | P | P | P | | P | P | P | | P | 5 | |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | | P | 5 | |
| Small Organs [1] | P | P | P | | P | P | P | | P | 5 | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | P | P | P | | P | P | P | | P | 5 | |
| Transesophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | | P | 5 | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | | P | 5 | |
| Musculo-skeletal Superficial [3] | P | P | P | | P | P | P | | P | 5 | |
| Other (Urological) | | | | | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler<br>(AD) | Combined<br>[4] | Color Velocity<br>Mapping (TVMI) | Harmonic<br>Imaging (TEI) | Other (specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | P | P | P | | P | P | P | P | P | S | |
| Abdominal | P | P | P | | P | P | P | P | P | S | |
| Intraoperative (Abdominal) | P | P | P | | P | P | P | P | P | S | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | P | P | S | |
| Small Organs [1] | P | P | P | | P | P | P | P | P | S | |
| Neonatal Cephalic | P | P | P | | P | P | P | P | P | S | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | N | N | N | | N | N | N | N | N | S | |
| Transesophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | P | P | S | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | P | P | S | |
| Musculo-skeletal Superficial [3] | P | P | P | | P | P | P | P | P | S | |
| Other (Urological) | | | | | | | | | | | |
| The SL3323 probe is already | | | | | | | | | | | |
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows: | | | | | | Mode of Operations | | | | | |
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler<br>(AD) | Combined<br>[4] | Color Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | N | N | N | | N | N | N | | N | 5 | |
| Small Organs [1] | N | N | N | | N | N | N | | N | 5 | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | N | N | N | | N | N | N | | N | 5 | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional [3] | N | N | N | | N | N | N | | N | 5 | |
| Musculo-skeletal Superficial [3] | N | N | N | | N | N | N | | N | 5 | |
| Other (Urological) | | | | | | | | | | | |
| The SI 2235 probe is to be | | | | | | | | | | | |
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows: | | | | | | Mode of Operations | | | | | |
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler<br>(AD) | Combined<br>[4] | Color Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) | |
| Ophthalmic | N | N | N | N | N | N | N | N | N | | |
| Fetal | N | N | N | N | N | N | N | N | N | | |
| Abdominal | N | N | N | N | N | N | N | N | N | | |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | N | N | N | N | N | N | N | N | N | | |
| Small Organs [1] | | | | | | | | | | | |
| Neonatal Cephalic | N | N | N | N | N | N | N | N | N | | |
| Adult Cephalic | N | N | N | N | N | N | N | N | N | | |
| Cardiac [2] | N | N | N | N | N | N | N…
