DC-6 DIAGNOSTIC ULTRASOUND SYSTEM

K072164 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · ITX · Sep 5, 2007 · Radiology

Device Facts

• Record ID: K072164
• Device Name: DC-6 DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: ITX · Radiology
• Decision Date: Sep 5, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• 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 abdominal, cardiac, small parts (breast, testes, thyroid, etc.), peripheral vascular, fetal, transrectal, transvaginal, pediatric, neonatal cephalic, musculoskeletal (general and superficial), Urology/Prostate and intraoperative (liver, gallbladder, pancreas).

Device Story

DC-6 Diagnostic Ultrasound System is a mobile, software-controlled device for general-purpose ultrasound imaging. It utilizes linear, phased, and convex array probes (2-12 MHz) to acquire and display images in B-Mode, M-Mode, Color, PW, CW, and Power/DirPower modes. Advanced imaging features include Smart3D (freehand 3D), iScape (panoramic), and Free Xros M (anatomic M). Operated by qualified physicians in clinical settings, the system processes ultrasound signals to produce real-time diagnostic images. These images assist clinicians in evaluating anatomy and pathology, supporting diagnostic decision-making across various clinical applications. The system benefits patients by providing non-invasive, real-time visualization of internal structures.

Clinical Evidence

Bench testing only. Acoustic output measured and calculated per NEMA UD 2 and NEMA UD 3 standards. Device conforms to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, and ISO 10993-1 safety standards. No clinical data presented.

Technological Characteristics

Mobile ultrasound system; 2-12 MHz linear, phased, and convex array transducers. Modes: B, M, Color, PW, CW, Power/DirPower. Features: Smart3D, iScape, Free Xros M, Tissue Harmonic Imaging. Connectivity: Standard ultrasound interface. Safety: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1. Software-controlled.

Indications for Use

Indicated for ultrasound imaging of abdominal, cardiac, small parts (breast, thyroid, testes), peripheral vascular, fetal, transrectal, transvaginal, pediatric, neonatal cephalic, musculoskeletal, and urological/prostate structures. Used by qualified physicians.

Regulatory Classification

Identification

A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.

Predicate Devices

• NEMIO SSA-550A (K010631)
• SSD-5000 (K012080)
• iU22 (K042540)
• Sonos 5500 (K990339)
• HD11 (K062247)
• Logiq 9 (K061129)

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

Date Prepared: Jun 21. 2007

#### 2. Device Name: DC-6 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 (90-1YO)

21 CFR 892.1570 Diagnostic Ultrasound Transducer (90-ITX)

#### 3. Marketed Device:

The subject device is substantially equivalent in its technologies and functionality to the original DC-6 Diagnostic Ultrasound System that is already cleared under premarket notification number K063500 and other predicate devices noted below:

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| Predicate Device | Manufacturer | Model | 510(k) Control Number |
|------------------|-----------------|----------------|-----------------------|
| First | Toshiba | NEMIO SSA-550A | K010631 |
| Second | Aloka | SSD-5000 | K012080 |
| Third | Philips | iU22 | K042540 |
| Fourth | Hewlett Packard | Sonos 5500 | K990339 |
| Fifth | Philips | HD11 | K062247 |
| Sixth | GE | Logiq 9 | K061129 |

## 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, CW 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, phased array and convex array with a frequency range of approximately 2 MHz to 12 MHz. The modified DC-6 Diagnostic Ultrasound System also provides Smart3D imaging (Free hand 3D). iScape imaging (panoramic imaging) and Free Xros M imaging (anatomic M).

## 5. Intended Use:

The device is intended for use by a qualified physician for ultrasound evaluation of abdominal, cardiac, small parts (breast, testes, thyroid, etc.), peripheral vascular, fetal, transrectal, transvaginal, pediatric, neonatal cephalic, musculoskeletal (general and superficial), Urology/Prostate and intraoperative (liver, gallbladder, pancreas).

## 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

PHATSIPERT DE LEBERT FREE MERKET PER TERRET DE PERSELLER PER LEGEN LE FART LE - JERDEREN LE

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demonstrate that the device is as safe and effective as the legally marketed predicate devices.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and features an abstract image of an eagle. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the top half of the circle.

SEP - 5 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K072164

Trade Name: DC-6 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, IYN and ITX Dated: August 3, 2007 Received: August 6, 2007

Dear Mr. Mosenkis:

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-6 Diagnostic Ultrasound System, as described in your premarket notification:

#### Transducer Model Number

$$\begin{array}{ll} \underline{\text{7L74}} \\ \underline{\text{2P2}} \\ \underline{\text{6L8}} \end{array} \tag{2.144} \\ \begin{array}{ll} \underline{\text{6LE7}} \\ \underline{\text{7L8}} \\ \underline{\text{6C2}} \end{array} \tag{2.145}$$

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

{4}------------------------------------------------

can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) 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 determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

> Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

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 contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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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If you have any questions regarding the content of this letter, please contact Mr. Paul Hardy at [phone].

Sincerely yours,

Arpit MWhag sn NCB

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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System Model: × Transduccr DC-6

510(k) Number(s)

| | Mode of Operation | | | | | | | | | |
|----------------------------------------------------------------------------------------------------|-------------------|---|---|---------|-----|------------------|----------------------|------------------------------|-----------------------|-----------------|
| Clinical Application | A | B | M | PW<br>D | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other (specify) |
| Ophthalmic | P | P | P | P | | P | P | | P | Note 1, 2, 4 |
| Fetal | P | P | P | P | | P | P | | P | Note 1, 2, 3,4 |
| Intraoperative (specify)* | N | N | N | N | | N | N | | N | Note 2, 3, 4 |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | P | P | P | P | | P | P | | P | Note 1, 2, 3,4 |
| Small organ(specify)* | P | P | P | P | | P | P | | P | Note 2, 3, 4 |
| Neonatal Cephalic | P | P | P | P | | P | P | | P | Note 2, 3, 4 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | P | P | P | N | | P | P | | P | Note 1, 4 |
| Transesophageal | | | | | | | | | | |
| Transrectal | P | P | P | P | | P | P | | P | Note 2, 4 |
| Transvaginal | P | P | P | P | | P | P | | P | Note 2, 4 |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | | P | P | | P | Note 2, 3, 4 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | P | | P | P | | P | Note 2, 3, 4 |
| Musculo-skeletal Superficial | P | P | P | P | | P | P | | P | Note 2, 3, 4 |
| Other (specify) *** | N | N | N | N | | N | N | | N | Note 1, 2, 4 |
| 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. | | | | | | | | | | |
| ** Intraoperative includes abdominal, thoracic, and vascular etc. | | | | | | | | | | |
| *** Other use includes Urology/Prostate. | | | | | | | | | | |
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | | | |
| Note 2: Smart3D | | | | | | | | | | |
| Note 3: iScape | | | | | | | | | | |
| Note 4: Free Xros M imaging | | | | | | | | | | |

(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)

JWhanx

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices K072164 510(k) Number -

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System

Model:

JUL 25 2007

| 510(k) Number(s) | | | | | | | | | | |
|---------------------------------------------------------------------------------------------------|-------------------|---|---|---------|-----|------------------|----------------------|------------------------------|-----------------------|-----------------|
| | Mode of Operation | | | | | | | | | |
| Clinical Application | A | B | M | PW<br>D | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | N | N | N | | N | N | | N | Note 2, 3, 4 |
| Intraoperative (specify)* | | N | N | N | | N | N | | N | Note 2, 3, 4 |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | N | N | N | | N | N | | N | Note 2, 3, 4 |
| Small organ(specify) ** | | N | N | N | | N | N | | N | Note 2, 3, 4 |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | N | N | N | | N | N | | N | Note 2, 3, 4 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | N | N | N | | N | N | | N | Note 2, 3, 4 |
| Musculo-skeletal Superficial | | N | N | N | | N | N | | N | Note 2, 3, 4 |
| 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. | | | | | | | | | | |
| ** Intraoperative includes abdominal, thoracic, and vascular etc. | | | | | | | | | | |
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | | | |
| Note 2: Smart3D | | | | | | | | | | |
| Note 3: iScape | | | | | | | | | | |
| Note 4: Free Xros M imaging | | | | | | | | | | |

Diagnostic Ultrasound Indications for Use Form

×

Transducer

7LT4

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

Nancyc Sradon
(Division Sign-Off)

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

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

# Mindray Co. Ltd. - DC-6 Diagnostic Ultrasound System

JUL 25 2007

#### Diagnostic Ultrasound Indications for Use Form

System Model:

510(k) Number(s)

Transducer × 2P2

| | | Mode of Operation | | | | | | | | | |
|--------------------------------------------------------------------------------------------------|---|-------------------|---|---------|-----|------------------|----------------------|------------------------------|-----------------------|-----------------|--|
| Clinical Application | A | B | M | PW<br>D | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other (specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (specify)* | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small organ(specify)" | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | N | N | N | N | N | N | | N | Note 1, 4 | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other (Urology) | | | | | | | | | | | |
| 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. | | | | | | | | | | | |
| ** Intraoperative includes abdominal, thoracic, and vascular etc. | | | | | | | | | | | |
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | | | | |
| Note 2: Smart3D | | | | | | | | | | | |
| Note 3: iScape | | | | | | | | | | | |
| Note 4: Free Xros M imaging | | | | | | | | | | | |

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

Nancy C.Bogdon
(Division Sign-Off)

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

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

## Mindray Co. Ltd. - DC-6 Diagnostic Ultrasound System

JUL 25 2007

## Diagnostic Ultrasound Indications for Use Form ×

Transducer

6LB7

System Model:

510(k) Number(s)

| | Mode of Operation | | | | | | | | | |
|---------------------------------------------------------------------------------------------------|-------------------|---|---|---------|-----|------------------|----------------------|------------------------------|-----------------------|-----------------|
| Clinical Application | A | B | M | PW<br>D | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other (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 | Note 2, 4 |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify)*** | | N | N | N | | N | N | | N | Note 2, 4 |
| 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. | | | | | | | | | | |
| ** Intraoperative includes abdominal, thoracic, and vascular etc. | | | | | | | | | | |
| *** Other use includes Urology/Prostate. | | | | | | | | | | |
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | | | |
| Note 2: Smart3D | | | | | | | | | | |
| Note 3: iScape | | | | | | | | | | |
| Note 4: Free Xros M imaging | | | | | | | | | | |

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

Nancy C. Boagdon

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

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

JUL 25 2007

System Model:

Transducer × 6LE7

510(k) Number(s)

| Mode of Operation | | | | | | | | | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---|---|---|---------|-----|------------------|----------------------|------------------------------|-----------------------|-----------------|
| Clinical Application | A | B | M | PW<br>D | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | N | N | N | | N | N | | N | Note 2, 4 |
| Abdominal | | N | N | N | | N | N | | N | Note 2, 5 |
| Intraoperative (specify)* | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small organ(specify)** | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | N | N | N | | N | N | | N | Note 2, 4 |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) *** | | N | N | N | | N | N | | N | Note 2, 4 |
| N=new indication; P=previously cleared by FDA; E=added under Appendix E<br>Additional comments: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW+B.<br>*Small organ-breast, thyroid, testes, etc.<br>** Intraoperative includes abdominal, thoracic, and vascular etc.<br>*** Other use includes Urology.<br>Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.<br>Note 2: Smart3D<br>Note 3: iScape | | | | | | | | | | |

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

Nancy C. Brogdon
(Division Sign-Off)

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

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

## Mindray Co. Ltd. - DC-6 Diagnostic Ultrasound System

JUL 25 2007

#### Diagnostic Ultrasound Indications for Use Form

System

Transducer メ

Model:

510(k) Number(s)

7L4A, 7L6, 10L4

| | 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 (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify)* | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small organ(specify)* | | E | E | E | | E | E | | E | Note 2, 3, 4 |
| Neonatal Cephalic | | E | E | E | | E | E | | E | Note 2, 3, 4 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | E | E | E | | E | E | | E | Note 2, 3, 4 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | E | E | E | | E | E | | E | Note 2, 3, 4 |
| Musculo-skeletal Superficial | | E | E | E | | E | E | | E | Note 2, 3, 4 |
| 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. | | | | | | | | | | |
| ** Intraoperative includes abdominal, thoracic, and vascular etc. | | | | | | | | | | |
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | | | |
| Note 2: Smart3D | | | | | | | | | | |
| Note 3: iScape | | | | | | | | | | |
| Note 4: Free Xros M imaging | | | | | | | | | | |

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

Nancyc. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal and

Radiological Devices 510(k) Number

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

JUL 25 2007

System Model:

Transducer 6C2

510(k) Number(s)

—

| Clinical Application | Mode of Operation | | | | | | | | | |
|-------------------------------|-------------------|---|---|---------|-----|------------------|----------------------|------------------------------|-----------------------|-----------------|
| | A | B | M | PW<br>D | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | N | N | N | | N | N | | N | Note 2, 4 |
| Intraoperative (specify)* | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | N | N | N | | N | N | | N | Note 2, 4 |
| Small organ(specify)** | | | | | | | | | | |
| Neonatal Cephalic | | N | N | N | | N | N | | N | Note 2, 4 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

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

Nancye Brogdon
(Division Sign-Off)

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

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

JUL 25 2007

System Model:

Transducer × 3CSA

510(k) Number(s)

| | Mode of Operation | | | | | | | | | |
|----------------------------------------------------------------------------------------------------|-------------------|---|---|---------|-----|------------------|----------------------|------------------------------|-----------------------|-----------------|
| Clinical Application | A | B | M | PW<br>D | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | E | E | E | | E | E | | E | Note 1, 2, 4 |
| Abdominal | | E | E | E | | E | E | | E | Note 1, 2, 4 |
| Intraoperative (specify)* | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | N | N | N | | N | N | | N | Note 1, 2, 4 |
| Small organ(specify)** | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (Urology) | | | | | | | | | | |
| 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. | | | | | | | | | | |
| ** Intraoperative includes abdominal, thoracic, and vascular etc. | | | | | | | | | | |
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | | | |
| Note 2: Smart3D | | | | | | | | | | |
| Note 3: iScape | | | | | |…