DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM

K113647 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · IYN · Dec 16, 2011 · Radiology

Device Facts

• Record ID: K113647
• Device Name: DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Dec 16, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), cardiac adult, cardiac pediatric, peripheral vessel and urology exams.

Device Story

Mobile, software-controlled diagnostic ultrasound system; acquires/displays images in B, M, PW, CW, Color, Color M, Power/Dirpower, TDI, 4D, and combined modes. Employs linear, convex, and phased array probes (3-10 MHz). Used in clinical settings by healthcare professionals for diagnostic imaging. System processes ultrasound signals to generate real-time images; supports features including Tissue Harmonic Imaging, Smart3D, 4D (real-time 3D), iScape, TDI, Color M, biopsy guidance, and elastography. Output displayed on system monitor for clinician interpretation to aid in diagnosis and clinical decision-making.

Clinical Evidence

Bench testing only. Evaluated for acoustic output, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, and mechanical safety. Conforms to IEC 60601-1, IEC 60601-2-37, IEC 62304, IEC 62366, ISO 14971, and ISO 10993-1 standards.

Technological Characteristics

Mobile ultrasound system; linear, convex, and phased array transducers (3-10 MHz). Modes: B, M, PW, CW, Color, Color M, Power/Dirpower, TDI, 4D. Software-controlled. Conforms to IEC 60601-1, IEC 60601-2-37, IEC 62304, IEC 62366, ISO 14971, ISO 10993-1, UL 60601-1, UD 2, and UD 3.

Indications for Use

Indicated for adults, pregnant women, pediatric patients, and neonates for fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal/adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal, cardiac, peripheral vessel, and urology ultrasound 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

• DC-7 (K103583)
• M7 (K103677)
• Voluson E8 (K101236)
• DC-T6 (K110199)
• M-Turbo (K101757)
• ACUSON S2000 (K112596)
• ACUSON SEQUOIA 512 (K063085)
• LOGIQ e (K102256)

Submission Summary (Full Text)

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# 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92(c).

The assigned 510(k) number is: < 113647.

# 1. Submitter:

Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China

Tel: [phone] Fax: [phone]

#### Contact Person:

Zhai Pei Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China

Date Prepared: October 17, 2011

#### 2. Device Name: DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic

Ultrasound System

Classification Regulatory Class: Il Review Category: Tier II 21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System (90-IYN) 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (90-1YO) 21 CFR 892.1570 Diagnostic Ultrasound Transducer (90-ITX)

### 3. Device Description:

DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, PW-Mode, CW mode, Color-Mode, Color M-Mode, Power/Dirpower Mode, TDI mode, 4D mode or the

B-1

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combined mode (i.e. B/M-Mode).This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array with a frequency range of approximately 3 MHz to 10.0 MHz.

### 4. Intended Use:

The DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), cardiac adult, cardiac pediatric, peripheral vessel and urology exams.

# 5. Comparison with Predicate Devices:

DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices:

| Predicate Device | Manufacturer | Model | 510(k) Control Number |
|------------------|--------------|--------------------|-----------------------|
| 1 | Mindray | DC-7 | K103583 |
| 2 | Mindray | M7 | K103677 |
| 3 | GE | Voluson E8 | K101236 |
| 4 | Mindray | DC-T6 | K110199 |
| 5 | Sonosite | M-Turbo | K101757 |
| 6 | Siemens | ACUSON S2000 | K112596 |
| 7 | Siemens | ACUSON SEQUOIA 512 | K063085 |
| 8 | GE | LOGIQ e | K102256 |

They have the similar technological characteristics, are comparable in key safety and effectiveness features, and have the same intended uses and basic operating modes as the predicate devices.

# 6. Non-clinical Tests:

DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical safety standards. This device has been designed to meet the following standards: IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC

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60601-2-37, IEC 62304, IEC 62366,UL 60601-1, ISO14971, UD 2, UD 3 and ISO 10993-1.

# Conclusion:

Intended uses and other key features are consistent with traditional clinical practices, FDA guidelines and established methods of patient examination. The design, development and quality process of the manufacturer confirms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards. Therefore, the DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Shenzhen Mindray Bio-Medical Electronics Co., LTD. % Mr. Jeff D. Rongero Senior Project Engineer Underwriters Laboratories Inc. 12 Laboratory Drive RESEARCH TRIANGLE PARK NC 27709

DEC 1 6 2011

Re: K113647

Trade/Device Name: DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8 EXP/DC-8S Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO and ITX Dated: December 8, 2011 Received: December 12, 2011

Dear Mr. Rongero:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.

This determination of substantial equivalence applies to the following transducers intended for use with the SonoSite Edge ™ Ultrasound System, as described in your premarket notification:

Transducer Model Number

| <span style="text-decoration: underline;">C5-2E</span><br><span style="text-decoration: underline;">C7-3E</span><br><span style="text-decoration: underline;">L12-3E</span> | <span style="text-decoration: underline;">L14-6NE</span><br><span style="text-decoration: underline;">L14-6WE</span><br><span style="text-decoration: underline;">P4-2E</span> | <span style="text-decoration: underline;">D6-2E</span><br><span style="text-decoration: underline;">D8-3E</span><br><span style="text-decoration: underline;">V11-3E</span> |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. 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); 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.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

If you have any questions regarding the content of this letter, please contact Lauren Hefner at [phone].

Sincerely yours,

Mary S. Pastel: Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

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# Indications for Use

510(k) Number (if known):

### Device Name: DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System

Indications For Use:

The DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), cardiac adult, cardiac pediatric, peripheral vessel and urology exams.

× Prescription Use (Part 21 CFR 801 Subpart D)

510K

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

Page 1 of ー

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### Diagnostic Ultrasound Indications For Use Format

DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System System: Transducer:

N/A

| Clinical Application | | | | | | | Mode of Operation | | | | |
|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|---------------------------------|-------------------|---------------------|---------------------|--------------------------|----------------------|-----------------------|-----------------------|-------------------|--|
| General (Track<br>I Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| | Fetal | N | N | N | N | N | N | N | Note 1, 2,3, 4,6,7 | | |
| | Abdominal | N | N | N | N | N | N | N | Note 1, 2,3, 4,5,6 | | |
| | Intra-operative (Specify*) | | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | |
| | Pediatric | N | N | N | N | N | N | N | Note 1, 2,3, 4,5,6 | | |
| | Small Organ (Specify**) | N | N | N | N | N | N | N | Note 1,2, 4,6,7 | | |
| Fetal Imaging &<br>Other | Neonatal Cephalic | N | N | N | N | N | N | N | Note 1, 2,4,5,6 | | |
| | Adult Cephalic | N | N | N | N | N | N | N | Note 1, 2,4,5,6 | | |
| | Trans-rectal | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 | | |
| | Trans-vaginal | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 | | |
| | Trans-urethral | | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | | |
| | Musculo-skeletal (Conventional) | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 | | |
| | Musculo-skeletal (Superficial) | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 | | |
| | Intravascular | | | | | | | | | | |
| | Cardiac Adult | N | N | N | N | N | N | N | Note 1, 2,4,5,6 | | |
| | Cardiac Pediatric | N | N | N | N | N | N | N | Note 1, 2,4,5,6 | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | N | N | N | N | N | N | N | Note 1, 2, 4,6, | | |
| | Other (Specify***) | N | N | N | N | N | N | N | Note 1, 2, 4,6, | | |
| | N=new indication: P=previously cleared by FDA: 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. | | | | | | | | | | |
| | Note 2: Smart3D | | | | | | | | | | |
| | Note 3:4D(Real-time 3D) | | | | | | | | | | |
| | Note 4: iScape | | | | | | | | | | |
| | Note5: TDI | | | | | | | | | | |
| | Note6: Color M | | | | | | | | | | |
| | Note7: Biopsy Guidance | | | | | | | | | | |
| | Note8: Elastography | | | | | | | | | | |
| | (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 (specify) | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| | Fetal | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 | | |
| | Abdominal | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 | | |
| | Intra-operative (Specify*) | | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | |
| | Pediatric | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 | | |
| | Small Organ (Specify**) | | | | | | | | | | |
| Fetal Imaging &<br>Other | Neonatal Cephalic | | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | | |
| | Trans-rectal | | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | | |
| | Musculo-skeletal (Conventional) | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 | | |
| | Musculo-skeletal (Superficial) | | | | | | | | | | |
| | Intravascular | | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 | | |
| | Other (Specify***) | | | | | | | | | | |
| | N=new indication; P=previously cleared by FDA; 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. | | | | | | | | | | |
| | Note 2: Smart3D | | | | | | | | | | |
| | Note 3:4D(Real-time 3D) | | | | | | | | | | |
| | Note 4: iScape<br>Note5: TDI | | | | | | | | | | |
| | Note6: Color M | | | | | | | | | | |
| | Note7: Biopsy Guidance | | | | | | | | | | |
| | Note8: Elastography | | | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | | | |
| | | | | | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | | | | |
| General (Track I Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| | Fetal | N | N | N | | N | N | N | Note 1, 2, 4,6,7 | | |
| | Abdominal | N | N | N | | N | N | N | Note 1, 2, 4,6,7 | | |
| | Intra-operative (Specify*) | | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | |
| | Pediatric | N | N | N | | N | N | N | Note 1, 2, 4,6,7 | | |
| | Small Organ (Specify**) | | | | | | | | | | |
| Fetal Imaging & | Neonatal Cephalic | | | | | | | | | | |
| Other | Adult Cephalic | | | | | | | | | | |
| | Trans-rectal | | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | | |
| | Musculo-skeletal (Conventional) | | | | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | | | |
| | Intravascular | | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | |
| Peripheral | Peripheral vessel | N | N | N | | N | N | N | Note 1, 2, 4,6,7 | | |
| vessel | Other (Specify***) | | | | | | | | | | |
| | N=new indication; P=previously cleared by FDA; | | | | | 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. | | | | | | | | | | |
| | Note 2: Smart3D | | | | | | | | | | |
| | Note 3:4D(Real-time 3D) | | | | | | | | | | |
| | Note 4: iScape | | | | | | | | | | |
| | Note5: TDI | | | | | | | | | | |
| | Note6: Color M | | | | | | | | | | |
| | Note7: Biopsy Guidance | | | | | | | | | | |
| | Note8: Elastography | | | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | | | |
| 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 (specify) | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| | Fetal | | | | | | | | | | |
| | Abdominal | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 | | |
| | Intra-operative (Specify*) | | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | |
| | Pediatric | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 | | |
| | Small Organ (Specify**) | N | N | N | N | N | N | N | Note 1,2, 4,6,7,8 | | |
| Fetal Imaging & | Neonatal Cephalic | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 | | |
| Other | Adult Cephalic | | | | | | | | | | |
| | Trans-rectal | | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | | |
| | Musculo-skeletal (Conventional) | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 | | |
| | Musculo-skeletal (Superficial) | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 | | |
| | Intravascular | | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | |
| Peripheral | Peripheral vessel | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 | | |
| vessel | Other (Specify*** ) | | | | | | | | | | |
| | N=new indication; P=previously cleared by FDA: E=added under Appendix E | | | | | | | | | | |
| | Additional comments: Combined modes--B+M、PW+B、Color +B、Power + B、PW +Color+B、PW +Color+B、Power + PW+B. | | | | | | | | | | |
| | * Intraoperative includes abdominal, thoracic, and vascular etc. | | | | | | | | | | |
| | * * Small organ-breast, thyroid, testes.<br>*** Other use includes Urology. | | | | | | | | | | |
| | Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | | | |
| | Note 2: Smart3D | | | | | | | | | | |
| | Note 3:4D(Real-time 3D) | | | | | | | | | | |
| | Note 4: iScape | | | | | | | | | | |
| | NoteS: TDI | | | | | | | | | | |
| | Note6: Color M<br>Note7: Biopsy Guidance | | | | | | | | | | |
| | Note8: Elastography | | | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | | | |
| | Concurrence of CDRH, Office of Device Evaluation(ODE) | | | | | | | | | | |
|…