M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM

K121010 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · IYN · Apr 19, 2012 · Radiology

Device Facts

• Record ID: K121010
• Device Name: M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Apr 19, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The M7/M7T Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in gynecology, obstetric, abdominal, pediatric, small parts (breast, thyroid), neonatal cephalic, transcranial, cardiac, transvaginal, transrectal, peripheral vascular, urology, orthopedic, and musculoskeletal (conventional and superficial), intraoperative and transesophageal(cardiac) exams.

Device Story

M7/M7T Diagnostic Ultrasound System is a portable, software-controlled ultrasound system. It acquires and displays images using B-Mode, M-Mode, PW-Mode, CW-Mode, Color-Mode, Color M-Mode, Power/Dirpower Mode, TDI mode, or combined modes. The system utilizes an array of probes (linear, convex, phased) with frequencies from 2.5 MHz to 10.0 MHz. Operated by clinicians in various clinical settings, the device provides real-time imaging and fluid flow analysis. Output is displayed on the system monitor for physician interpretation to support clinical decision-making in diagnostic exams. Benefits include non-invasive visualization of internal structures and blood flow, aiding in the diagnosis and management of various patient conditions.

Clinical Evidence

Bench testing only. The device was evaluated for acoustic output, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, and mechanical safety. It conforms to standards including UD 2, UD 3, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, and ISO 10993-1.

Technological Characteristics

Portable ultrasound system; linear, convex, and phased array transducers (2.5-10.0 MHz). Modes: B, M, PW, CW, Color, Color M, Power/Dirpower, TDI. Standards: IEC 60601-1, IEC 60601-2-37, ISO 10993-1, IEC 62304. Software-controlled. Features: Tissue Harmonic Imaging, Smart3D, 4D (Real-time 3D), iScape, Biopsy Guidance, Amplitude Doppler.

Indications for Use

Indicated for adults, pregnant women, pediatric patients, and neonates for diagnostic ultrasound imaging or fluid flow analysis in gynecology, obstetric, abdominal, pediatric, small parts (breast, testes, thyroid), neonatal cephalic, transcranial, cardiac, transvaginal, transrectal, peripheral vascular, urology, orthopedic, musculoskeletal (conventional and superficial), intraoperative, and transesophageal (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

• Mindray M7/M7T (K103677)
• Mindray DC-7 (K103583)
• Mindray DC-8 (K113647)
• GE Logiq 7 (K03218)
• Philips iU22 (K093563)

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: KIQIOIQ

#### 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:

Yang Zhaohui

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: January 15, 2012

2. Device Name: M7/M7T Diagnostic Ultrasound System

#### Classification

Regulatory Class: II

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-IYO)

21 CFR 892.1570 Diagnostic Ultrasound Transducer (90-ITX)

#### 3. Device Description:

M7/M7T Diagnostic Ultrasound System is a general purpose, portable/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 or the 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

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Image /page/0/Picture/21 description: The image shows the text '005-1' in a bold, sans-serif font. The numbers are aligned horizontally, with a hyphen separating '005' from '1'. The text is black against a white background, creating a high contrast.

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and phased array with a frequency range of approximately 2.5 MHz to 10.0 MHz.

### 4. Intended Use:

The M7/M7T Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in gynecology, obstetric, abdominal, pediatric, small parts (breast, thyroid), neonatal cephalic, transcranial, cardiac, transvaginal, transrectal, peripheral vascular, urology, orthopedic, and musculoskeletal (conventional and superficial), intraoperative and transesophageal(cardiac) exams.

### 5. Comparison with Predicate Devices:

M7/M7T Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices:

| Predicate<br>Device | Manufacturer | Model | 510(k) Control<br>Number |
|---------------------|--------------|---------|--------------------------|
| 1 | Mindray | M7/M7T | K103677 |
| 2 | Mindray | DC-7 | K103583 |
| 3 | Mindray | DC-8 | K113647 |
| 4 | GE | Logiq 7 | K03218 |
| 5 | Philips | iU22 | K093563 |

They have the same 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:

M7/M7T 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: UD 2, UD 3, IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-37,UL 60601-1, ISO14971, ISO 10993-1, IEC62304 and IEC60601-2-18.

#### Conclusion:

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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 M7/M7T Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it and a pair of wings at the top.

#### Public Health Service

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

Re: K121010

Trade/Device Name: M7/M7T 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: March 30, 2012 Received: April 3, 2012

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 M7/M7T Diagnostic Ultrasound System, as described in your premarket notification:

### Transducer Model Number

| C5-2s | P7-3s | L14-6Ns |
|---------|--------|---------|
| V10-4s | 4CD4s | P12-4s |
| V10-4Bs | 6C2s | CW2s |
| 7L4s | 7L5s | 7LT4s |
| L14-6s | L7-3s | P7-3Ts |
| P4-2s | L12-4s | |

APR 1 9 2012

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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,

Damme M. Morris

anine M. Morris Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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## Indications for Use

510(k) Number (if known): ·

Device Name: M7/M7T Diagnostic Ultrasound System

Indications For Use:

The M7/M7T Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in gynecology, obstetric, abdominal, pediatric, small parts (breast, testes, thyroid), neonatal cephalic, transcranial, cardiac, transvaginal, transrectal, peripheral vascular, urology, orthopedic,and musculoskeletal(conventional and superficial); intraoperative and transesophagel (cardiac) exams.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (Part 21 CFR 801 Subpart D) 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)

Ranny Shouss
(Division Sign-
Division of Radiologica
Office of In Vitro Diagnostic Device Evalu
510K K121010

Page 1 of

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#### Diagnostic Ultrasound Indications for Use Form M7/M7T 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<br>(Track 1 Only) | Specific<br>(Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | P | P | P | P | P | P | Note 1,2,3,4,6,7,8 |
| | Abdominal | P | P | P | P | P | P | Note 1,2,3,4,5,6,7,8 |
| | Intraoperative (specify)* | N | N | N | N | N | N | Note1,2,4,6,7,8 |
| | Intraoperative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | P | P | P | Note 1,2,3,4,5,6,7,8 |
| | Small organ(specify)** | P | P | P | P | P | P | Note 1,2,4,6,7,8 |
| Fetal<br>Imaging<br>& Other | Neonatal Cephalic | P | P | P | P | P | P | Note 1,2,4,5,6,7,8 |
| | Adult Cephalic | P | P | P | P | P | P | Note 1,2,4,5,6,7,8 |
| | Trans-rectal | P | P | P | P | P | P | Note 1,2,4,6,7,8 |
| | Trans-vaginal | P | P | P | P | P | P | Note 1,2,4,6,7,8 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph.(non-Card.) | | | | | | | |
| | Musculo-skeletal Conventional | P | P | P | P | P | P | Note 1,2,4,5,6,7,8 |
| | Musculo-skeletal Superficial | P | P | P | P | P | P | Note 1,2,4,6,7,8 |
| | Intravascular | | | | | | | |
| | Other (specify)*** | P | P | P | P | P | P | Note 1, 2, 4,6,7,8 |
| | Cardiac Adult | P | P | P | P | P | P | Note 1,2,5,6,7,8 |
| | Cardiac Pediatric | P | P | P | P | P | P | Note 1,2,5,6,7,8 |
| Cardiac | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | N | N | N | N | N | N | Note 1,2,5,6,8 |
| | Intra-Cardiac | | | | | | | |
| Peripheral<br>Vascular | Peripheral Vascular | P | P | P | P | P | P | Note 1, 2, 4,6,7,8 |
| | 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, PW +Color+B, PW +Color+B, Power + PW +B.

*Intraoperative includes abdominal, thoracic, and vascular.

- **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: Amplitude Doppler

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K121010

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| System: | M7/M7T Diagnostic Ultrasound System | | | | | | | |
|-----------------------------|------------------------------------------------------------------------------------|-------------------|---|-----|-----|----------------------------|-------------------------------|--------------------|
| Transducer: | C5-2s | | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | |
| General<br>(Track 1 Only) | Specific<br>(Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler (specify) | Combined<br>Doppler (specify) | Other (specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | P | P | P | | P | P | Note 1, 2, 4,6,7,8 |
| | Abdominal | P | P | P | | P | P | Note 1, 2, 4,6,7,8 |
| | Intraoperative (specify)* | | | | | | | |
| | Intraoperative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | P | Note 1, 2, 4,6,7,8 |
| Fetal<br>Imaging<br>& Other | Small organ(specify)** | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph.(non-Card.) | | | | | | | |
| | Musculo-skeletal Conventional | | | | | | | |
| | Musculo-skeletal Superficial | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (specify)*** | | | | | | | |
| | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-Cardiac | | | | | | | |
| Peripheral<br>Vascular | Peripheral Vascular | P | P | P | | P | P | Note 1, 2, 4,6,7,8 |
| | Other (specify) | | | | | | | |

N=new indication; P=previously cleared by FDA; E=added under Appendix E

1+1cw multed.com, 1 - provents: B+M, PW+B, Color + B, Power + B, PW +Color+B, Power + PW +B.

*Intraoperative includes abdominal, thoracic, and vascular.

- **Small organ-breast, thyroid, testes.
***Other use includes urology.

. Note I: 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: Amplitude Doppler

(Division Sign-Off)
Division of Radiological Devices

Show

Olyision of Sacrologic Evaluation and Safety Office of 10

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Transducer:

### Diagnostic Ultrasound Indications for Use Form

#### M7/M7T Diagnostic Ultrasound System System:

V 10-4s

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

| Clinical Application | | Mode of Operation | | | | | | |
|-----------------------------|-------------------------------|-------------------|---|-----|-----|------------------|-----------------------|--------------------|
| General<br>(Track 1 Only) | Specific<br>(Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Fetal | P | P | P | | P | P | Note 1, 2, 4,6,7,8 |
| | Abdominal | | | | | | | |
| | Intraoperative (specify)* | | | | | | | |
| | Intraoperative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small organ(specify)** | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | P | P | P | | P | P | Note 1, 2, 4,6,7,8 |
| | Trans-vaginal | P | P | P | | P | P | Note 1, 2, 4,6,7,8 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph.(non-Card.) | | | | | | | |
| | Musculo-skeletal Conventional | | | | | | | |
| | Musculo-skeletal Superficial | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (specify)*** | P | P | P | | P | P | Note 1, 2, 4,6,7,8 |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra-Cardiac | | | | | | | |
| Peripheral<br>Vascular | Peripheral Vascular | | | | | | | |
| | 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, PW +Color+B, PW +Color+B, Power + PW +B.

*Intraoperative includes abdominal, thoracic, and vascular.

- **Small organ-breast, thyroid, testes.
- ***()ther 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
- Note7: Biopsy Guidance
- Note8: Amplitude Doppler

(Division Sign-Off)

Division of Radiological Devices Vitro Diagnosuc Device Evaluation and Safety Office o n

**008-4**

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M7/M7T Diagnostic Ultrasound System

i

Transducer: Intended Use:

System:

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

V 10-4Bs

| Clinical Application | | Mode of Operation | | | | | | |
|-----------------------------|-------------------------------|-------------------|---|-----|-----|----------------------------|-------------------------------|--------------------|
| General<br>(Track 1 Only) | Specific<br>(Track 1 & 3) | B | M | PWD | CWD | Color Doppler<br>(specify) | Combined<br>Doppler (specify) | Other (specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | P | P | P | | P | P | Note 1, 2, 4,6,7,8 |
| | Abdominal | | | | | | | |
| | Intraoperative (specify)* | | | | | | | |
| | Intraoperative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small organ(specify)** | | | | | | | |
| Fetal<br>Imaging<br>& Other | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | P | P | P | | P | P | Note 1, 2, 4,6,7,8 |
| | Trans-vaginal | P | P | P | | P | P | Note 1, 2, 4,6,7,8 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph.(non-Card.) | | | | | | | |
| | Musculo-skeletal Conventional | | | | | | | |
| | Musculo-skeletal Superficial | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (specify)*** | P | P | P | | P | P | Note 1, 2, 4,6,7,8 |
| | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra-Cardiac | | | | | | | |
| Peripheral<br>Vascular | Peripheral Vascular | | | | | | | |
| | 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, PW +Color+B, PW +Color+B, Power + PW +B.

*Intraoperative includes abdominal, thoracic, and vascular.

- **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
- NoteS: TDI
- Note6: Color M
- Note7: Biopsy Guidance
- Note8: Amplitude Doppler

(Division Sign-Off)
Division of Radiological Devices
Office of la Vitro Dieynestic Device Evaluation and Safe

રાજ્યન

008-5

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M7/M7T Diagnostic Ultrasound System

System: Transducer:

7L4s .

Intended· Use:

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

| Clinical Application | | Mode of Operation | | | | | | |
|-----------------------------|-------------------------------|-------------------|---|-----|-----|----------------------------|-------------------------------|-------------------|
| General<br>(Track 1 Only) | Specific<br>(Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler (specify) | Combined<br>Doppler (specify) | Other (specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | P | P | P | | P | P | Note 1,2, 4,6,7,8 |
| | Intraoperative (specify)* | | | | | | | |
| | Intraoperative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | P | Note 1,2, 4,6,7,8 |
| | Small organ(specify)** | P | P | P | | P | P | Note 1,2, 4,6,7,8 |
| Fetal<br>Imaging<br>& Other | Neonatal Cephalic | P | P | P | | P | P | Note 1,2, 4,6,7,8 |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph.(non-Card.) | | | | | | | |
| | Musculo-skeletal Conventional | P | P | P | | P | P | Note 1,2, 4,6,7,8 |
| | Musculo-skeletal Superficial | P | P | P | | P | P | Note 1,2, 4,6,7,8 |
| | Intravascular | | | | | | | |
| | Other (specify)*** | | | | | | | |
| | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra-Cardiac | | | | | | | |
| Peripheral<br>Vascular | Peripheral Vascular | P | P | P | | P | P | Note 1,2, 4,6,7,8 |
| | 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, PW +Color+B, PW +Color+B, Power + PW +B.

*Intraoperative includes abdominal, thoracic, and vascular.

- ** Small organ-breast, thyroid, testes.
***Other use includes urology.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Smart3D T

Note 3:4D(Real-time 3D)

Note 4: iScape

Note5: TDI

Note6: Color M

Note7: Biopsy Guidance

Note8: Amplitude Doppler

Evaluation and Salety

(Divisio Division of Radiological Devices Office വങ്ങ

રાભ

008-6

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M7/M7T Diagnostic Ultrasound System

System: Transducer:

L 14-65

Intended Use:

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

| Clinical Application | | | Mode of Operation | | | | | | |
|-----------------------------|-------------------------------|--|-------------------|---|-----|-----|------------------|-----------------------|-------------------|
| General<br>(Track.1 Only) | Specific<br>(Track 1 & 3) | | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intraoperative (specify)* | | | | | | | | |
| | Intraoperative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | P | P | P | P | P | P | Note 1,2, 4,6,7,8 |
| | Small organ(specify)** | | P | P | P | P | P | P | Note 1,2, 4,6,7,8 |
| Fetal<br>Imaging<br>& Other | Neonatal Cephalic | | P | P | P | P | P | P | Note 1,2, 4,6,7,8 |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card.) | | | | | | | | |
| | Musculo-skeletal Conventional | | P | P | P | P | P | P | Note 1,2, 4,6,7,8 |
| | Musculo-skeletal Superficial | | P | P | P | P | P | P | Note 1,2, 4,6,7,8 |
| | Intravascular | | | | | | | | |
| | Other (specify)*** | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | | |
| | Intra-Cardiac | | | | | | | | |
| Peripheral<br>Vascular | Peripheral Vascular. | | P | P | P | P | P | P | Note 1,2, 4,6,7,8 |
| | Other (specify) | | | | | | | | |

N=new indication; P=previously cleared by FDA; E=added under Appendix E

N=Hitw mureats:Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+B, Power + PW+B.

*Intraoperative includes abdominal, thoracic, and vascular.

- **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: Amplitude Doppler

Vhune Harts
(Division Sign-Off)

510K

Division ME adiolonical na Office 1910

{12}------------------------------------------------

| | Diagnostic Ultrasound Indications for Use Form | | | | | | | | |
|-----------------------------|------------------------------------------------------------------------------------|---------------------------|---|---|-----|-----|------------------|-----------------------|-----------------|
| System: | M7/M7T Diagnostic Ultrasound System | | | | | | | | |
| Transducer: | P4-2s | | | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | |
| | Clinical Application | Mode of Operation | | | | | | | |
| | General<br>(Track 1 Only) | Specific<br>(Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| | Abdominal | P | P | P | P | P | P | Note 1, 2,5,6,7,8 | |
| | Intraoperative (specify)* | | | | | | | | |
| | Intraoperative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | P | P | P | Note 1, 2,5,6,7,8 | |
| | Small organ(specify)** | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Neonatal Cephalic | P | P | P | P | P | P | Note 1, 2,5,6,7,8 | |
| | Adult Cephalic | P | P | P | P | P | P | Note 1, 2,5,6,7,8 | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card.) | | | | | | | | |
| | Musculo-skeletal Conventional | | | | | | | | |
| | Musculo-skeletal Superficial | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (specify)*** | | | | | | | | |
| | Cardiac Adult | P | P | P | P | P | P | Note 1, 2,5,6,7,8 | |
| | Cardiac Pediatric | P | P | P | P | P | P | Note 1, 2,5,6,7,8 | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | | |
| | Intra-Cardiac | | | | | | | | |
| Peripheral<br>Vascular | Peripheral Vascular | | | | | | | | |
| | 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, PW+Color+B, PW +Color+B, Power + PW +B.

*Intraoperative includes abdominal, thoracic, and vascular.

- **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

NoteS: TDI

Note6: Color M

Note7: Biopsy Guidance

Note8: Amplitude Doppler

(Division Sign-Off)
Division of Radiological Devices
Office of in Vitro Diagnostic Device Evaluation and Safety
510K.

{13}------------------------------------------------

M7/M7T Diagnostic Ultrasound System

System: Transducer:

P7-3s

Intended Use:

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

| Clinical Application | | Mode of Operation | | | | | | | |
|-----------------------------|-------------------------------|-------------------|---|-----|-----|------------------|-------------------------------|-----------------|--|
| General<br>(Track 1 Only) | Specific<br>(Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>Doppler (specify) | Other (specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| | Abdominal | P | P | P | P | P | P | Note 1, 2,5,6,8 | |
| | Intraoperative (specify)* | | | | | | | | |
| | Intraoperative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | P | P | P | Note 1, 2,5,6,8 | |
| | Small organ(specify)** | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Neonatal Cephalic | P | P | P | P | P | P | Note 1, 2,5,6,8 | |
| | Adult Cephalic | P | P | P | P | P | P | Note 1, 2,5,6,8 | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal Conventional | P | P | P | P | P | P | Note 1, 2,5,6,8 | |
| | Musculo-skeletal Superficial | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (specify)*** | | | | | | | | |
| | Cardiac Adult | P | P | P | P | P | P | Note 1, 2,5,6,8 | |
| | Cardiac Pediatric | P | P | P | P | P | P | Note 1, 2,5,6,8 | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-Cardiac | | | | | | | | |
| Peripheral<br>Vascular | Peripheral Vascular | | | | | | | | |
| | 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, PW+Color+B, PW +Color+B, Power + PW+B.

*Intraoperative includes abdominal, thoracic, and vascular.

**Small organ-breast, thyroid, testes.

***Other use includes urology.

Note I: 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: Amplitude Doppler

Kausan thers
(Division Sign-Off)
Division of Radiological Devices

office office office office office office office office office office office office office office office office office office office office office office office office office valuation and Safety

રાભ

{14}------------------------------------------------

| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | |
|-----------------------------|------------------------------------------------------------------------------------|-------------------|---|-----|-----|----------------------------|-------------------------------|--------------------|
| | Clinical Application | Mode of Operation | | | | | | |
| General<br>(Track 1 Only) | Specific<br>(Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler (specify) | Combined<br>Doppler (specify) | Other (specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | P | P | P | | P | P | Note1,2, 3, 4,6,8 |
| | Abdominal | P | P | P | | P | P | Note 1,2, 3, 4,6,8 |
| | Intraoperative (specify)* | | | | | | | |
| | Intraoperative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | P | P | P | | P | P | Note1,2, 3, 4,6,8 |
| | Small organ(specify)** | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph.(non-Card.) | | | | | | | |
| | Musculo-skeletal Conventional | | | | | | | |
| | Musculo-skeletal Superficial | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (specify)*** | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra-Cardiac | | | | | | | |
| Peripheral | Peripheral Vascular | | | | | | | |
| Vascular | Other (specify) | | | | | | | |

M7/M7T Diagnostic Ultrasound System

4CD4s

Transducer:

System:

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional comments:Combined modes: B+M, PW+B, Color + B, PW +Color+B, PW +Color+B, Power + PW +B.

*Intraoperative includes abdominal, thoracic, and vascular.

** 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

Evaluation and Safety

Note8 Amplitude Doppler

(Division Sign-Off)
Division A Radiological Devices
Office of in Vitro Versio

II

{15}------------------------------------------------

| Clinical Application | | Mode of Operation | | | | | | |
|-----------------------------|-------------------------------|-------------------|---|-----|-----|------------------|-----------------------|--------------------|
| General<br>(Track 1 Only) | Specific<br>(Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | P | P | P | | P | P | Note 1, 2, 4,6,7,8 |
| | Intraoperative (specify)* | | | | | | | |
| | Intraoperative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | P | Note 1, 2, 4,6,7,8 |
| | Small organ(specify)** | | | | | | | |
| Fetal<br>Imaging<br>& Other | Neonatal Cephalic | P | P | P | | P | P | Note 1, 2, 4,6,7,8 |
| | Adult Cephalic | P | P | P | | P | P | Note 1, 2, 4,6,7,8 |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph.(non-Card.) | | | | | | | |
| | Musculo-skeletal Conventional | P | P | P | | P | P | Note 1, 2, 4,6,7, |
| | Musculo-skeletal Superficial | P | P | P | | P | P | Note 1, 2, 4,6,7,- |
| | Intravascular | | | | | | | |
| | Other (specify)*** | | | | | | | |
| | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-Cardiac | | | | | | | |
| | | | | | | | | |
| Peripheral<br>Vascular | Peripheral Vascular | P | P | P | | P | P | Note 1, 2, 4,6,7, |
| | Other (specify) | | | | | | | |

.

M7/M7T Diagnostic Ultrasound System

6C2s

Transducer:

System:

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional comments:Combined modes: B+M, PW+B, Color + B, PW +Color+B, PW +Color+B, Power + PW +B.

*Intraoperative includes abdominal, thoracic, and vascular.

- **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: Amplitude Doppler

(Division Bign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation

510K

aluzion and Salety

008-11

{16}------------------------------------------------

#### Diagnostic Ultrasound Indications for Use Form M7/M7T Diagnostic Ultrasound System

Transducer: Intended Use:

System:

7L5s Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | Mode of Operation | | | | | | |
|-----------------------------|-------------------------------|-------------------|---|-----|-----|------------------|-----------------------|-------------------|
| General<br>(Track 1 Only) | Specific<br>(Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic. | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intraoperative (specify)* | | | | | | | |
| | Intraoperative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | P | P | P | Note 1,2, 4,6,7,8 |
| | Small organ(specify)** | P | P | P | P | P | P | Note 1,2, 4,6,7,8 |
| Fetal<br>Imaging<br>& Other | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph.(non-Card.) | | | | | | | |
| | Musculo-skeletal Conventional | P | P | P | P | P | P | Note 1,2, 4,6,7,8 |
| | Musculo-skeletal Superficial | P | P | P | P | P | P | Note 1,2, 4,6,7,8 |
| | Intravascular | | | | | | | |
| | Other (specify)*** | | | | | | | |
| | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra-Cardiac | | | | | | | |
| Peripheral<br>Vascular | Peripheral Vascular | P | P | P | P | P | P | Note 1,2, 4,6,7,8 |
| | 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, PW+Color+B, PW +Color+B, Power + PW+B.

*Intraoperative includes abdominal, thoracic, and vascular.

- **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

NoteS: TDI

- Note6: Color M
- Note7: Biopsy Guidance

Amplitude Doppler

evice Evaluation and Safety

Raune Shaus
(Division Sign-Off)
Division of Radiological Devices

Vitto Diagnos

Office of In:

**008-12**

{17}------------------------------------------------

| System: | M7/M7T Diagnostic Ultrasound System | | | | | | | |
|-----------------------------|------------------------------------------------------------------------------------|---------------------------|---|---|-----|-----|----------------------------|-----------------------|
| Transducer: | L7-3s | | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | |
| | Clinical Application | | | | | | | |
|…