DC-7 DIAGNOSTIC ULTRASOUND SYSTEM

K103583 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · IYN · Dec 27, 2010 · Radiology

Device Facts

• Record ID: K103583
• Device Name: DC-7 DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Dec 27, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The DC-7 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in abdominal, cardiac, small organ (breast, testes, thyroid, etc.), peripheral vascular, fetal, transrectal; transvaginal, pediatric, transcranial (adult cephalic and neonatal cephalic), musculoskeletal (conventional and superficial}, intraoperative, and urology exams.

Device Story

DC-7 Diagnostic Ultrasound System; portable, software-controlled ultrasound diagnostic system. Inputs: ultrasound echoes via array probes (linear, convex, phased, volume; 1.8-12.0 MHz). Processing: transmission of ultrasonic energy; post-processing of received echoes. Outputs: B-mode, M-mode, Color, Color M, CW, Power/DirPower, TDI, and combined modes (e.g., B/M) displayed on-screen. Used in clinics/hospitals by clinicians for anatomical/fluid flow visualization and measurements. Features include STIC, Stress Echo, iPage, Tissue Harmonic Imaging, Smart3D, 4D, iScape, and biopsy guidance. Output aids clinical decision-making by providing diagnostic imaging for various patient populations and exam types.

Clinical Evidence

Bench testing only. Evaluated for acoustic output, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, and mechanical safety. Conforms to standards including UD 2, UD 3, IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-1-4, and ISO 10993-1.

Technological Characteristics

Portable ultrasound system; frequency range 1.8-12.0 MHz. Probes: linear, convex, phased, volume. Features: Tissue Harmonic Imaging, Smart3D, 4D, iScape, TDI, Color M, biopsy guidance. Standards: IEC 60601-1, IEC 60601-2-37, ISO 10993-1. Software-controlled.

Indications for Use

Indicated for adults, pregnant women, pediatric patients, and neonates. Used for abdominal, cardiac, small organ (breast, testes, thyroid), peripheral vascular, fetal, transrectal, transvaginal, transcranial (adult/neonatal cephalic), musculoskeletal (conventional/superficial), intraoperative, and urology 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 (K101041)
• DC-3 (K091941)
• Voluson E8 (K061682)
• VIVID 7 (K060542)
• LOGIQ5 Expert (K032974)
• Acuson CV70 (K050240)
• Acuson Sequoia 512 (K052410)
• LOGIQ P5 (K060993)

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: ( 03583

# 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

### Contact Person:

Meng Xianjun 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]

Date Prepared: Sept. 25, 2010

### 2. Device Name: DC-7 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. Predicate Device(s):

DC-7 Diagnostic Ultrasound System is substantially equivalent to the following devices. 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 device.

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| Predicate<br>Device | Manufacturer | Model | 510(k) Control Number |
|---------------------|--------------|--------------------|-----------------------|
| 1 | Mindray | DC-7 | K101041 |
| 2 | Mindray | DC-3 | K091941 |
| 3 | GE | Voluson E8 | K061682 |
| 4 | GE | VIVID 7 | K060542 |
| 5 | GE | LOGIQ5 Expert | K032974 |
| 6 | Siemens | Acuson CV70 | K050240 |
| 7 | Siemens | Acuson Sequoia 512 | K052410 |
| 8 | GE | LOGIQ P5 | K060993 |

# 4. Device Description:

The DC-7 Diagnostic Ultrasound System is a general purpose, portable, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-mode, M-mode, Color mode, Color M mode, CW mode, CW 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 probe, convex array probe, phased array probe and volume probe with a frequency range of approximately 1.8 MHz to 12.0 MHz.

This modification will provide users with 3 additional transducers, some additional optional features called STIC, Stress Echo, iPage, and etc. These modifications all lead to overall quality and image enhancement.

### 5. Intended Use:

The DC-7 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in abdominal, cardiac, small organ (breast, testes, thyroid, etc.), peripheral vascular, fetal, transvaginal, pediatric, transcranial (adult cephalic and neonatal cephalic), musculoskeletal (conventional and superficial), intraoperative, and urology exams.

### 6. Non-clinical Tests:

DC-7 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 60601-2-37 ,IEC 60601-1-4 and ISO 10993-1.

#### 7. Technological Characteristics:

The DC-7 Diagnostic Ultrasound System has the same technological characteristics with the predicate devices. All systems transmit ultrasonic energy into patients, then perform

{2}------------------------------------------------

post processing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body. All system allow for specialized measurements of structures and flow, and calculations.

#### 7.Conclusion:

The DC-7 Diagnostic Ultrasound System has the same technological characteristics, key safety and effectiveness features, and has the same intended uses and basic operating modes as the predicate devices.

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, ISO9001 and ISO13485 quality systems. The device conforms to applicable medical device safety standards. Therefore, the DC-7 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 logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

#### 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

DFC 2 7 2010

Re: K103583

Trade/Device Name: DC-7 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 3, 2010 Received: December 7, 2010

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 DC-7 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

| 3C5A | L12-4 | P7-3 |
|--------|-------|--------|
| C5-2 | L7-3 | P12-4 |
| V10-4 | L11-4 | 7LT4 |
| V10-4B | L14-6 | DE10-3 |
| 6C2 | 2P2 | 6LB7 |
| 7L4A | 4CD4 | 6LE7 |
| 7L5 | P4-2 | CB10-4 |

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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 Paul Hardy at [phone].

Sincerely yours.

David G. Brown, Ph.D. Acting 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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K(.03S8-3

# Indications for Use

510(k) Number (if known):

DEC 2 7 2010

Device Name: DC-7 Diagnostic Ultrasound System

Indications For Use:

The DC-7 Diagnostic Ultrasound System is applicable for adults, pregnant women,pediatric patients and neonates. It is intended for use in abdominal, cardiac, small organ (breast, testes, thyroid, etc.), peripheral vascular, fetal, transrectal; transvaginal, pediatric, transcranial (adult cephalic and neonatal cephalic), musculoskeletal (conventional and superficial}, intraoperative, and urology exams.

Prescription Use __x

AND/OR

ﺎ Over-The-Counter ﺎ

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subp

Page 1 of __1_

(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

510K K103583

008-1

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| System | X | | | Transducer | | | | | | | |
|----------------------------------------------------------------------------------------------------|-------------------|---|------|------------|------------------|----------------------|-----------------------|---------------------|--|--|--|
| Model: | | | DC-7 | | | | | | | | |
| 510(k) Number(s) | | | | | | | | | | | |
| | | | | | | | | | | | |
| | Mode of Operation | | | | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | P | P | P | P | P | P | P | Note 1,2, 3, 4,6,7 | | | |
| Abdominal | P | P | P | P | P | P | P | Note 1, 2, 3, 4,5,6 | | | |
| Intraoperative (specify)* | P | P | P | P | P | P | P | Note 1,2, 4,6,7 | | | |
| Intraoperative (Neuro) | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | Note 1, 2, 4,5,6, | | | |
| Small organ(specify)** | P | P | P | P | P | P | P | Notel, 2, 4,6,7 | | | |
| Neonatal Cephalic | P | P | P | P | P | P | P | Notel, 2, 4,5,6,7 | | | |
| Adult Cephalic | P | P | P | P | P | P | P | Notel, 2, 4,5,6,7 | | | |
| Trans-rectal | P | P | P | P | P | P | P | Note 1,2,3,4,6,7 | | | |
| Trans-vaginal | P | P | P | P | P | P | P | Note 1,2,3,4,6,7 | | | |
| Trans-urethral | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | Note 1,2,4,6,7 | | | |
| Musculo-skeletal Superficial | P | P | P | P | P | P | P | Note 1,2,4,6,7 | | | |
| Intravascular | | | | | | | | | | | |
| Cardiac Adult | P | P | P | P | P | P | P | Note 1,2,5,6,7 | | | |
| Cardiac Pediatric | P | P | P | P | P | P | P | Note 1,2,5,6,7 | | | |
| Intravascular (Cardiac) | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | |
| Intra-Cardiac | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | Note 1,2,4,6,7 | | | |
| Other (specify)*** | N | N | N | N | N | N | N | Note 1,2,4,6,7 | | | |
| 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, etc. | | | | | | | | | | | |
| *** 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 | | | | | | | | | | | |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation(ODE)

i

. .

Prescription USE (Per 21 CFR 801.109)

---

(Division Sign Off)

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

510K K163583

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Image /page/7/Figure/0 description: The image shows the text "Mindray Co. Ltd.- DC-7 Diagnostic Ultrasound System". The text appears to be a product name or a company name and product description. The text is written in a simple, sans-serif font and is horizontally aligned. The text is likely part of a product label, advertisement, or informational material related to medical equipment.

| Model: | | | 3C5A | | | | | |
|------------------------------------------------------------------------------------------------------|-------------------|---|------|-----|------------------|----------------------|-----------------------|-----------------|
| 510(k) Number(s) | | | | | | | | |
| | | | | | | | | |
| Clinical Application | Mode of Operation | | | | | | | |
| | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | | | | | | | | |
| Fetal | P | P | P | | P | P | P | Note 1, 2, 4,6, |
| Abdominal | P | P | P | | P | P | P | Note 1, 2, 4,6, |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | Note 1, 2, 4,6, |
| Small organ(specify)** | | | | | | | | |
| 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, |
| Musculo-skeleta! Superficial | | | | | | | | |
| Intravascular | | | | | | | | |
| Cardiac Adult | | | | | | | | |
| Cardiac Pediatric | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | Note 1, 2, 4,6, |
| 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 etc. | | | | | | | | |
| * * Small organ-breast, thyroid, testes, etc. | | | | | | | | |
| *** 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 | | | | | | | | |

Transducer

×

Model:

**008-3**

Prescription USE (Per 21 CFR 801.109)

።

(Division Sign-Off)
Division of Radiological D

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

510K

System

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. "

Prescription USE (Per 21 CFR 801.109)

| Model: | | | CS-2 | Transducer | X | | | |
|--------------------------------------------------------------------------------------------------|-------------------|---|------|------------|------------------|----------------------|-----------------------|-----------------|
| 510(k) Number(s) | | | | | | | | |
| | | | | | | | | |
| | Mode of Operation | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | | | | | | | | |
| Fetal | P | P | P | | P | P | P | Note 1, 2, 4,6 |
| Abdominal | P | P | P | | P | P | P | Note 1, 2, 4,6 |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | Note 1, 2, 4,6 |
| Small organ(specify)** | | | | | | | | |
| 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 |
| Musculo-skeletal Superficial | | | | | | | | |
| Intravascular | | | | | | | | |
| Cardiac Adult | | | | | | | | |
| Cardiac Pediatric | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | Note 1, 2, 4,6 |
| 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, etc. | | | | | | | | |
| ***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 | | | | | | | | |
| Note 5: TDI | | | | | | | | |
| Note6: Color M | | | | | | | | |
| Note7: Biopsy Guidance | | | | | | | | |
| | | | | | | | | |

# Diagnostic Ultrasound Indications for Use Form ﺍﻟﺨﺪﺍﻡ ﺍﻟ

'Transducer

×

System

Concurrence of CDRH, Office of Device Evaluation(ODE)

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

510K K103583

008-4

{9}------------------------------------------------

·

:

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

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, etc.

***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

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription USE (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K103583510K

# Diagnostic Ultrasound Indications for Use Form

V 10-4

Transducer

×

System Model:

008-5

.

{10}------------------------------------------------

| : :<br>- | ్రాల్యేక | ี | |
|----------|----------|---|--|
| | | | |
| | | | |

# Mindray Co. Ltd.- DC-7 Diagnostic Ultrasound System

| System | | Transducer | X |
|------------------|--------|------------|---|
| Model: | V10-4B | | |
| 510(k) Number(s) | | | |

| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) |
|-------------------------------|---|---|-----|-----|---------------|-------------------|--------------------|------------------|
| Ophthalmic | | | | | | | | |
| Fetal | P | P | P | | P | P | P | Note 1, 2, 4,6,7 |
| Abdominal | | | | | | | | |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | | | | | | | | |
| Small organ(specify)** | | | | | | | | |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Trans-rectal | P | P | P | | P | P | P | Note 1, 2, 4,6,7 |
| Trans-vaginal | P | P | P | | P | P | P | Note 1, 2, 4,6,7 |
| Trans-urethral | | | | | | | | |
| Trans-esoph.(non-Card.) | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | |
| Intravascular | | | | | | | | |
| Cardiac Adult | | | | | | | | |
| Cardiac Pediatric | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | |
| Peripheral Vascular | | | | | | | | |
| Other (specify)*** | N | N | N | | N | N | N | Note 1,2,4,6,7 |

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, etc.

***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

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

| Prescription USE (Per 21 CFR 801.109) | (Division Sign-Off)<br>Division of Radiological Devices<br>Office of In Vitro Diagnostic Device Evaluation and Safety |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------|

510K. K103583

Diagnostic Ultrasound Indications for Use Form

י

:

008-6

{11}------------------------------------------------

1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1

System Model:

. : Transducer × ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------6C2

510(k) Number(s)

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

Prescription USE (Per 21 CFR 801.109)

9)

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

510K

5582

008-7

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

: -

،

System Model:

Transducer ×

5 ! 0(k) Number(s)

7L4A

| | Mode of Operation | | | | | | | |
|-------------------------------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|----------------------|-----------------------|-----------------|
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | | | | | | | | |
| Fetal | | | | | | | | |
| Abdominal | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| Small organ(specify)** | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| Neonatal Cephalic | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| 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 |
| Musculo-skeletal Superficial | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| Intravascular | | | | | | | | |
| Cardiac Adult | | | | | | | | |
| Cardiac Pediatric | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | 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, PW +Color+ B, PW +Color+ B, Power + PW +B, | | | | | | | | |
| * Intraoperative includes abdominal, thoracic, and vascular etc. | | | | | | | | |
| ** Small organ-breast, thyroid, testes, etc. | | | | | | | | |
| *** 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 | | | | | | | | |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | | | | | | | | |
| Concurrence of CDRH, Office of Device Evaluation(ODE) | | | | | | | | |

Prescription USE (Per 21 CFR 801,109)

23 : 3 . !! .!! #f

・!・ミダ・ト・

... .. .

. -

..............................................................................................................................................................................

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

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

510K K103583

008-8

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

7L5

System Model:

Transducer ×

510(k) Number(s)

| | | | | | Mode of Operation | | | |
|------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---|-----|-----|-------------------|----------------------|-----------------------|-----------------|
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | | | | | | | | |
| Felal | | | | | | | | |
| Abdominal | p | P | P | | P | P | p | Note 1,2, 4,6,7 |
| ntraoperative (specify)* | | | | | | | | |
| ntraoperative (Neuro) | | | | | | | | |
| aparoscopic | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| Small organ(specify)** | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| Neonatal Cephalic | b | P | P | | P | P | P | Note 1,2, 4,6,7 |
| 1 :<br>Adult Cephalic | : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : | | . - | | | | | |
| r<br>Trans-rectal | Texas P | | | | | | | |
| Trans-vaginal | | | | | | | | |
| Trans-urethral | | | | | | | | |
| Trans-esoph (non-Card.) | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | | P | P | p | Note 1,2, 4,6,7 |
| Musculo-skeletal Superficial | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| ntravascular | | | | | | | | |
| Cardiac Adult | | | | | | | | |
| Cardiac Pediatric | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph.(Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| Other (specify)*** | | | | | | | | |
| V=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 etc. | | | | | | | | |
| ** Small organ-breast, thyroid, testes, etc. | | | | | | | | |
| ** * 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 | | | | | |…