DC-6 DIAGNOSTIC ULTRASOUND SYSTEM

K063500 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · IYN · Dec 6, 2006 · Radiology

Device Facts

• Record ID: K063500
• Device Name: DC-6 DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Dec 6, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The device is intended for use by a qualified physician for ultrasound evaluation of adult abdomen, adult cardiology, pediatric abdomen, pediatric cardiology, fetal cardiology, gynecology, obstetrics (first trimester, second and third trimester), kidney, prostate, thyroid, breast, and other small parts, and peripheral vascular (peripheral artery and peripheral vein), and carotid scanning.

Device Story

Mobile, software-controlled ultrasound system; acquires/displays images in B-Mode, M-Mode, Color, PW, Power/DirPower, and combined modes (e.g., B/M). Employs linear and convex array probes (2.5–12 MHz). Used by qualified physicians in clinical settings for diagnostic imaging. System processes acoustic signals to generate real-time visual output for clinical evaluation. Supports Tissue Harmonic Imaging. Output assists physicians in diagnostic decision-making across various anatomical regions. Benefits include non-invasive diagnostic visualization of internal structures and vascular flow.

Clinical Evidence

Bench testing only. Acoustic output measured per NEMA UD 2 and NEMA UD 3 standards. Conformance to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, and ISO 10993-1 safety standards.

Technological Characteristics

Mobile ultrasound system; linear and convex array transducers (2.5–12 MHz). Modes: B, M, PW, Color, Power/DirPower, Tissue Harmonic Imaging. Conforms to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, and ISO 10993-1. Software-controlled.

Indications for Use

Indicated for ultrasound evaluation of adult/pediatric patients for abdominal, cardiac, fetal cardiac, gynecological, obstetric, urological (kidney, prostate), small parts (thyroid, breast, testes), and peripheral vascular (artery, vein, carotid) applications.

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

• Toshiba NEMIO SSA-550A (K010631)
• Toshiba FAMIO SSA-530A (K051500)
• Aloka SSD-5000 (K012080)
• Philips iU22 (K042540)
• Siemens SONOLINE G60 S (K052894)
• Siemens Sequoia 512 (K052410)
• Mindray DP-9900 (K061189)

Submission Summary (Full Text)

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#### 510(K) SUMMARY Exhibit B

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:

### 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:

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

October 16, 2006 Date Prepared:

2. Device Name: DC-6 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-FYO)

21 CFR 892.1570 Diagnostic Ultrasound Transducer (90-ITX)

### 3. Marketed Device:

DC-6 Diagnostic Ultrasound System is substantially equivalent to the following devices: Toshiba NEMIO SSA-550A (K#010631) and FAMIO SSA-530A (K#051500), Aloka SSD-5000 (K#012080), Philips iU22 (K#042540), Siemens SONOLINE G60 S (K#052894) and Sequoia 512 (K#052410), Mindray DP-9900 (#K061189).

0042

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### 4. Device Description:

The DC-6 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound mages in B-Mode, M-Mode, Color mode, PW mode, Power/DirPower 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 and convex linear array with a frequency range of approximately 2.5 MHz to 12 MHz.

### 5. Intended Use:

The device is intended for use by a qualified physician for ultrasound evaluation of adult abdomen, adult cardiology, pediatric abdomen, pediatric cardiology, fetal cardiology, gynecology, obstetrics (first trimester, second and third trimester), kidney, prostate, thyroid, breast, and other small parts, and peripheral vascular (peripheral artery and peripheral vein), and carotid scanning.

### 6. Safety Considerations:

The DC-6 Diagnostic Ultrasound System has been tested as Track 3 Device per the FDA Guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" issued September 1997. The acoustic output is measured and calculated per NEMA UD 2 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment: 2004 and NEMA UD 3 Output Display Standard. The device conforms to applicable medical device safety standards, such as IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37 and ISO 10993-1.

#### Conclusion:

The conclusions drawn from testing of the DC-6 Diagnostic Ultrasound System demonstrate that the device is as safe and effective as the legally marketed predicate devices.

0043

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, all facing to the right. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 4 2006

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Mr. Robert Mosenkis President Citech 5200 Butler Pike PLYMOUTH MEETING PA 19462-1298

Re: K063500

Trade Name: DC-6 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: November 17, 2006 Received: November 20, 2006

Dear Mr. Mosenkis:

This letter corrects our substantially equivalent letter of December 6, 2006.

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.

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## Page 2 - Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

3C1

This determination of substantial equivalence applies to the following transducers intended for I mis determination of backs of our as described in your premarket notification:

#### Transducer Model Number

6CV1

7L4

૩૮૨

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 it may be subject to back additions, Title 21, Parts 800 to 898. In addition, FDA oun or louits in ther announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loast be advisou mail i Driv issum that your device complies with other requirements of the Act that I Dri has made a dollations 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 CITY art 607), adoning (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (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 This letter will anow you to orgin manunting of your device to a legally marketed nonication. The I Driving of casting 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 IT you desire specific at 12-12-12-12-120. Also, please note the regulation entitled, Contact the Office of Confightalso as (2 + notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your response Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

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Page 3 - Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

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

Sincerely yours,

David h. hyman

f

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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3500

× System

Transducer

Model:

DC-6

510(k) Number(s)

| | Mode of Operation | | | | | | | | | | |
|-------------------------------------------------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | N | N | N | | N | N | | N | N | |
| Abdominal | | N | N | N | | N | N | | N | N | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | N | N | N | | N | N | | N | N | |
| Small organ(specify) | | N | N | N | | N | N | | N | | |
| Neonatal Cephalic | | N | N | N | | N | N | | N | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | N | N | N | | N | N | | N | N | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | N | N | N | | N | N | | N | | |
| Transvaginal | | N | N | N | | N | N | | N | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | N | N | N | | N | N | | N | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | N | N | N | | N | N | | N | | |
| Musculo-skeletal Superficial | | N | N | N | | N | N | | N | | |
| Other (specify) | | | | | | | | | | | |
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | | | | | | | | | | | |

A dditional comments: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B,

Power + PW +B.

*Other: Tissue Harmonic Imaging. The feature does not use contrast agents.

**Small organ-breast, thyroid, testes, etc.

(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)

0047

Division of Reproductive, Abdor and Radiological Devices 510(k) Number

{6}------------------------------------------------

| System | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
|--------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| Model: | | 3CS |

× Transducer

510(k) Number(s)

| 4 | | |
|---|--|--|

| | Mode of Operation | | | | | | | | | | |
|------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | N | N | N | | N | N | | N | N | |
| Abdominal | | N | N | N | | N | N | | N | N | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small organ(specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | |
| Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |

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

Power + PW +B.

*Other: Tissue Harmonic Imaging. The feature does not use contrast agents.

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

510(k) Number _

Concurrence of CDRH, Office of Device Evaluation(ODE)

David h. Slayton
(Division Sign-Off)

Division of Reproductive, Abdominal, Prescription USE (Per 21 CFR 801.109) and Radiological Devices

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System

Transducer ×

3CI Model:

510(k) Number(s)

D6 5500

| Clinical Application | Mode of Operation | | | | | | | | | |
|------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | N | N | N | | N | N | | N | N |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | N | N | N | | N | N | | N | N |
| Small organ(specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | N | N | N | | N | N | | N | N |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| 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.

*Other: Tissue Harmonic Imaging. The feature does not use contrast agents.

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

David le. Leggans. 0043

(Division Sign-Off) Division of Reproductive, Abdom and Radiological Devices 510(k) Number

Prescription USE (Per 21 CFR 801.109)

{8}------------------------------------------------

| System | |
|------------------|---------|
| Transducer | X |
| Model: | 6CV1 |
| 510(k) Number(s) | K063500 |

| | Mode of Operation | | | | | | | | | | |
|------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small organ(specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | N | N | N | | N. | N | | N | | |
| Transvaginal | | N | N | N | | N | N | | N | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | |
| Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |

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

Power + PW +B.

(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) 4
Division of Reproductive, Abdominal,.
and Radiological Devices
510(k) Number K063500

0050

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

System Model:

Transducer

7L4

510(k) Number(s)

K068500

×

| | Mode of Operation | | | | | | | | | | |
|-------------------------------------------------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small organ(specify) ** | | N | N | N | | N | N | | N | | |
| Neonatal Cephalic | | N | N | N | | N | N | | N | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | N | N | N | | N | N | | N | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | N | N | N | | N | N | | N | | |
| Musculo-skeletal Superficial | | N | N | N | | N | N | | N | | |
| 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.

** Small organ-breast, thyroid, testes, etc.

(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)

0051

(Division Sign-Off)
Division of Reproductive, Abdominal,..
and Radiological Devices
510(k) Number K063500