TE7 Diagnostic Ultrasound System

K160381 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · IYN · Mar 9, 2016 · Radiology

Device Facts

• Record ID: K160381
• Device Name: TE7 Diagnostic Ultrasound System
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Mar 9, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

TE7 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, intra-operative(abdominal, thoracic, and vascular), pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-esoph. (Cardiac), trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), urology, peripheral vessel, adult and pediatric cardiac exams.

Device Story

TE7 is a software-controlled diagnostic ultrasound system; acquires/displays ultrasound data in B-Mode, M-Mode, CW-Mode, Color-Mode, Power/Dirpower Mode, Tissue Harmonic Imaging (THI), and Left Ventricular Opacification (LVO); supports combined modes (e.g., B/M, B/PW, B/PW/Color). System utilizes array probes (linear/convex) with 3.0-10.0 MHz frequency range. Used in clinical settings (e.g., OR, clinic) by trained healthcare professionals. Device transmits ultrasonic energy into patients; processes received echoes to generate onscreen anatomical/flow displays; performs specialized measurements/calculations. Output assists clinicians in diagnostic decision-making and patient management. Benefits include non-invasive visualization of internal structures and blood flow.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including acoustic output measurements (UD 2, UD 3), electrical/mechanical safety (AAMI/ANSI ES60601-1, IEC 60601-2-37), electromagnetic compatibility (IEC 60601-1-2), biocompatibility (ISO 10993-1), and software life cycle processes (IEC 62304).

Technological Characteristics

Ultrasonic pulsed Doppler/echo imaging system. Employs linear and convex array transducers (3.0-10.0 MHz). Modes: B, M, CW, Color, Power/Dirpower, THI, LVO, and combined modes. Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, ISO 14971, and IEC 62304. Software-controlled.

Indications for Use

Indicated for adults, pregnant women, pediatric patients, and neonates for diagnostic ultrasound imaging or fluid flow analysis in fetal, abdominal, intra-operative, pediatric, small organ, neonatal/adult cephalic, trans-esophageal (cardiac), trans-rectal, trans-vaginal, musculoskeletal, urology, peripheral vessel, and cardiac exams.

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

• TE7 (K143472)
• ZONARE ZS3 (K151175)
• Mindray M9/M9 CV/M9T (K152543)

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 caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is rendered in black, and the text is also in black.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Mr. Wu Zicui Engineer of Technical Regulation Department Mindray Building, Keji 12th Road South Hi-tech Industrial Park, Nanshan Shenzhen, Guangdong 518057 CHINA

Re: K160381

Trade/Device Name: TE7 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: January 27, 2016 Received: February 10, 2016

Dear Mr. Zicui:

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.

March 9, 2016

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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 [phone] or [phone] 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 [phone] or [phone] 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

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

## 510(k) Number (if known) K160381

Device Name TE7 Diagnostic Ultrasound System

#### Indications for Use (Describe)

TE7 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, intra-operative(abdominal, thoracic, and vascular), pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-esoph. (Cardiac), trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), urology, peripheral vessel, adult and pediatric cardiac exams.

| Type of Use (Select one or both, as applicable) |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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#### Diagnostic Ultrasound Indications For Use Format

TE7 Diagnostic Ultrasound System System:

Transducer: N/A

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 (Track 1 & 3) | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) |
| Fetal Imaging<br>& Other | Ophthalmic | | | | | | | | |
| | Fetal | P | P | P | | P | P | P | Note 1,2 |
| | Abdominal | P | P | P | P | P | P | P | Note 1,2 |
| | Intra-operative (Specify*) | P | P | P | | P | P | P | Note 1,2 |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | P | P | P | P | Note 1,2 |
| | Small Organ (Specify**) | P | P | P | | P | P | P | Note 1,2 |
| | Neonatal Cephalic | P | P | P | | P | P | P | Note 1,2 |
| | Adult Cephalic | P | P | P | | P | P | P | Note 1,2 |
| | Trans-rectal | P | P | P | | P | P | P | Note 1,2 |
| | Trans-vaginal | P | P | P | | P | P | P | Note 1,2 |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | P | P | P | | P | P | P | Note 1,2 |
| | Musculo-skeletal<br>(Superficial) | P | P | P | | P | P | P | Note 1,2 |
| | Intravascular | | | | | | | | |
| | Cardiac Adult | P | P | P | P | P | P | P | Note 1,2,3 |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | P | Note 1,2 |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | P | P | P | P | P | P | P | Note 1 |
| | Intra-cardiac | | | | | | | | |
| | Peripheral<br>vessel | Peripheral vessel | P | P | P | P | P | P | P |
| | | Other (Specify***) | P | P | P | | P | P | P |

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# C11-3s

System: TE7 Diagnostic Ultrasound System

Transducer: C11-3s

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | Mode of Operation | | | | | | | | |
|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|----------------------------------------|---|-----|-----|------------------|----------------------|-----------------------|--------------------|--|
| | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other<br>(specify) | |
| General (Track 1 Only) | | | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | | | | | | | | | |
| | Abdominal | P | P | P | | P | P | P | Note 1,2 | |
| | Intra-operative (Specify*) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | Note 1,2 | |
| | Small Organ (Specify**) | | | | | | | | | |
| | Neonatal Cephalic | P | P | P | | P | P | P | Note 1,2 | |
| Fetal Imaging<br>& Other | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | |
| Cardiac | Cardiac Pediatric | P | P | P | | P | P | P | Note 1,2 | |
| | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| | | | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | P | P | P | | P | P | P | Note 1,2 | |
| | Other (Specify***) | | | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | | | |
| General (Track 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | P | P | P | | P | P | P | Note 1,2 | |
| | Abdominal | P | P | P | | P | P | P | Note 1,2 | |
| | Intra-operative (Specify*) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | Note 1,2 | |
| | Small Organ (Specify**) | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | |
| Fetal Imaging<br>& Other | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | P | P | P | | P | P | P | Note 1,2 | |
| | Other (Specify***) | | | | | | | | | |
| | N=new indication; P=previously cleared by FDA K143472; E=added under Appendix E | | | | | | | | | |
| | | | | | | | | | | |
| | *Intraoperative includes abdominal, thoracic, and vascular etc. | | | | | | | | | |
| | **Small organ-breast, thyroid, testes. | | | | | | | | | |
| | ***Other use includes Urology. | | | | | | | | | |
| | Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | | |
| | Note2: Biopsy Guidance | | | | | | | | | |
| | Note3: Contrast imaging (Contrast agent for LVO) | | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | | |
| | Concurrence of CDRH, Office of Device Evaluation(ODE) | | | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | | | |
| General (Track 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | | | | | | | | | |
| | Abdominal | | | | | | | | | |
| | Intra-operative (Specify*) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | | | | | | | | | |
| | Small Organ (Specify**) | | | | | | | | | |
| Fetal Imaging<br>& Other | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | P | P | P | P | P | P | P | Note 1 | |
| | Intra-cardiac | | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | | | | | | | | | |
| | Other (Specify***) | | | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | | | |
| General (Track<br>1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other<br>(specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | | | | | | | | | |
| | Abdominal | P | P | P | | P | P | P | Note 1,2 | |
| | Intra-operative (Specify*) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | Note 1,2 | |
| | Small Organ (Specify**) | P | P | P | | P | P | P | Note 1,2 | |
| | Neonatal Cephalic | | | | | | | | | |
| Fetal Imaging<br>& Other | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | P | P | P | | P | P | P | Note 1,2 | |
| | Musculo-skeletal<br>(Superficial) | P | P | P | | P | P | P | Note 1,2 | |
| | Intravascular | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| Cardiac<br>Peripheral<br>vessel | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| | Peripheral vessel | P | P | P | | P | P | P | Note 1,2 | |
| | Other (Specify***) | | | | | | | | | |
| | N=new indication; P=previously cleared by FDA K143472; E=added under Appendix E | | | | | | | | | |
| | Additional comments: Combined modes--B+M、PW+B、Color + B、Power+B、PW+Color+B、Power + PW +B. | | | | | | | | | |
| | *Intraoperative includes abdominal, thoracic, and vascular etc. | | | | | | | | | |
| | **Small organ-breast, thyroid, testes. | | | | | | | | | |
| | ***Other use includes Urology. | | | | | | | | | |
| | Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | | |
| | Note2: Biopsy Guidance | | | | | | | | | |
| | Note3: Contrast imaging (Contrast agent for LVO) | | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | | |
| | Concurrence of CDRH, Office of Device Evaluation(ODE) | | | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | | | |
| General (Track 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other<br>(specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | | | | | | | | | |
| | Abdominal | P | P | P | | P | P | P | Note 1,2 | |
| | Intra-operative (Specify*) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | Note 1,2 | |
| | Small Organ (Specify**) | P | P | P | | P | P | P | Note 1,2 | |
| | Neonatal Cephalic | | | | | | | | | |
| Fetal Imaging<br>& Other | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | P | P | P | | P | P | P | Note 1,2 | |
| | Musculo-skeletal<br>(Superficial) | P | P | P | | P | P | P | Note 1,2 | |
| | Intravascular | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | P | P | P | | P | P | P | Note 1,2 | |
| | Other (Specify***) | | | | | | | | | |
| N=new indication; P=previously cleared by FDA K143472; E=added under Appendix E | | | | | | | | | | |
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B. | | | | | | | | | | |
| *Intraoperative includes abdominal, thoracic, and vascular etc. | | | | | | | | | | |
| **Small organ-breast, thyroid, testes. | | | | | | | | | | |
| ***Other use includes Urology. | | | | | | | | | | |
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | | | |
| | Note2: Biopsy Guidance | | | | | | | | | |
| | Note3: Contrast imaging (Contrast agent for LVO) | | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | | |
| | Concurrence of CDRH, Office of Device Evaluation(ODE) | | | | | | | | | |
| Clinical Application | Mode of Operation | | | | | | | | | |
| General (Track<br>1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other<br>(specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | | | | | | | | | |
| | Abdominal | | | | | | | | | |
| | Intra-operative (Specify*) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | Note 1,2 | |
| | Small Organ (Specify**) | P | P | P | | P | P | P | Note 1,2 | |
| | Neonatal Cephalic | P | P | P | | P | P | P | Note 1,2 | |
| Fetal Imaging<br>& Other | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | P | P | P | | P | P | P | Note 1,2 | |
| | Musculo-skeletal<br>(Superficial) | P | P | P | | P | P | P | Note 1,2 | |
| | Intravascular | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | P | P | P | | P | P | P | Note 1,2 | |
| | Other (Specify***) | | | | | | | | | |
| N=new indication; P=previously cleared by FDA K143472; E=added under Appendix E | | | | | | | | | | |
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B. | | | | | | | | | | |
| *Intraoperative includes abdominal, thoracic, and vascular etc. | | | | | | | | | | |
| **Small organ-breast, thyroid, testes. | | | | | | | | | | |
| ***Other use includes Urology. | | | | | | | | | | |
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | |…