DC-T6 DIAGNOSTIC ULTRASOUND SYSTEM

K110199 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · IYN · Feb 8, 2011 · Radiology

Device Facts

• Record ID: K110199
• Device Name: DC-T6 DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Feb 8, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The DC-T6 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), cardiac(adult, pediatric), peripheral vascular and urology exams.

Device Story

DC-T6 is a mobile, software-controlled diagnostic ultrasound system. It acquires and displays ultrasound images using linear, convex, and phased array probes (2.5–10.0 MHz). Operating modes include B-Mode, M-Mode, PW-Mode, CW-Mode, Color-Mode, Color M-Mode, Power/Dirpower Mode, TDI, and combined modes (e.g., B/M). Used in clinical settings by healthcare professionals for imaging and fluid flow analysis. Output is displayed on the system monitor for diagnostic interpretation, supporting clinical decision-making across various anatomical regions. Features include Tissue Harmonic Imaging, Smart3D, 4D (real-time 3D), iScape, and biopsy guidance. System aids in patient examination and diagnosis.

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 60601-2-37, ISO 14971, and ISO 10993-1.

Technological Characteristics

Mobile ultrasound system; frequency range 2.5–10.0 MHz. Probes: linear, convex, phased array. Modes: B, M, PW, CW, Color, Power, TDI. Standards: IEC 60601-1, IEC 60601-2-37, ISO 10993-1. Software-controlled. Connectivity: standard ultrasound system interfaces.

Indications for Use

Indicated for adults, pregnant women, pediatric patients, and neonates. Clinical applications include fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal/adult cephalic, trans-rectal, trans-vaginal, musculoskeletal (conventional, superficial), cardiac (adult, pediatric), peripheral vascular, 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

• Mindray M7 (K100830)
• Mindray DC-3 (K091941)
• Mindray DC-7 (K101041)
• GE VIVID 7 (K060542)
• GE LOGIQ E (K091374)

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: KII 0199.

## 1. Submitter:

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

Tel: [phone] Fax: [phone]

Contact Person:

Zhai Pei

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

Date Prepared: December 8, 2010

2. Device Name: DC-T6 Diagnostic Ultrasound System

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

## 3. Device Description:

DC-T6 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, PW-Mode, CW mode, Color-Mode, Color M-Mode, Power/Dirpower Mode, TDI mode 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 and phased array

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with a frequency range of approximately 2.5 MHz to 10.0 MHz.

## 4. Intended Use:

The DC-T6 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), cardiac(adult, pediatric), peripheral vascular and urology exams.

## 5. Comparison with Predicate Devices:

DC-T6 Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices:

| Predicate Device | Manufacturer | Model | 510(k) Control Number |
|------------------|--------------|---------|-----------------------|
| 1 | Mindray | M7 | K100830 |
| 2 | Mindray | DC-3 | K091941 |
| 3 | Mindray | DC-7 | K101041 |
| 4 | GE | VIVID 7 | K060542 |
| 5 | GE | LOGIQ E | K091374 |

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:

DC-T6 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 and ISO 10993-1.

## Conclusion:

Intended uses and other key features are consistent with traditional clinical practices, FDA guidelines and established methods of patient examination. The design, development and quality process of the manufacturer confirms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems. The device conforms to applicable medical device

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safety standards. Therefore, the DC-T6 Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market. ﺩ

.

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

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

FEB - 8 2011

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: K110199

Trade/Device Name: DC-T6 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: January 20, 2011 Received: January 24, 2011

Dear Mr Rongero:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent ffor 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-T6 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

3C5A L7-3 7L4A P4-7 CS-2 2P2 L11-4 6C2 4CD4 L12-4 V10-4 715 V10-4B

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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 Shahram Vaezy at [phone].

Enclosure(s)

Sincerely Yours.

Mary S Pasted

Mary Pastel, ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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K110199

## Indications for Use

510(k) Number (if known):

Device Name: DC-T6 Diagnostic Ultrasound System

Indications For Use:

The DC-T6 Diagnostic Ultrasound System is applicable for adults, pregnant women,pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculoskeletal(conventional, superficial), cardiac(adult, pediatric), peripheral vascular and urology exams .

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter U (21 CFR 807 Subp

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

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

Page 1 of __ 1

Mary S. Pastel
(Division Sign-Off)

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K110199

008-1

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DC-T6 Diagnostic Ultrasound System

Transducer: Intended Use:

System:

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

| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) |
|----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|---|-----|-----|------------------|----------------------|-----------------------|----------------------|
| Ophthalmic | | | | | | | | |
| Fetal | N | N | N | | N | N | N | Note 1,2, 3, 4,6,7 |
| Abdominal | N | N | N | N | N | N | N | Note 1,2, 3, 4,5,6,7 |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | N | N | N | N | N | N | N | Note 1, 2, 4,5,6,7 |
| Small organ(specify)** | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 |
| Neonatal Cephalic | N | N | N | N | N | N | N | Note 1, 2, 4,5,6,7 |
| Adult Cephalic | N | N | N | N | N | N | N | Note 1, 2, 4,5,6,7 |
| Trans-rectal | N | N | N | N | N | N | N | Note 1,2,4,6,7 |
| Trans-vaginal | N | N | N | N | N | N | N | Note 1,2,4,6,7 |
| Trans-urethral | | | | | | | | |
| Trans-esoph.(non-Card.) | | | | | | | | |
| Musculo-skeletal Conventional | N | N | N | N | N | N | N | Note 1,2,4,6,7 |
| Musculo-skeletal Superficial | N | N | N | N | N | N | N | Note 1,2,4,6,7 |
| Intravascular | | | | | | | | |
| Cardiac Adult | N | N | N | N | N | N | N | Note 1,2,5,6,7 |
| Cardiac Pediatric | N | N | N | N | N | N | N | Note 1,2,5,6,7 |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | |
| Peripheral Vascular | N | N | N | N | N | N | N | Note 1,2,4,6,7 |
| Other (specify)*** | N | N | N | N | N | N | N | Note 1,2,4,6,7 |
| Transducer: | 3C5A | | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | |
| | Mode of Operation | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | | | | | | | | |
| Fetal | N | N | N | | N | N | N | Note 1, 2, 4,6 |
| Abdominal | N | N | N | | N | N | N | Note 1, 2, 4,6 |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | | | | | | | | |
| Small organ(specify)** | | | | | | | | |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Trans-rectal | | | | | | | | |
| Trans-vaginal | | | | | | | | |
| 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 | N | N | N | | N | N | N | 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, | | | | | | | | |
| ** 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 | | | | | | | | |
| Note S: TDI | | | | | | | | |
| Note6: Color M | | | | | | | | |
| Note7: Biopsy Guidance | | | | | | | | |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | | | | | | | | |
| | Mode of Operation | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) |
| Ophthalmic | | | | | | | | |
| Fetal | N | N | N | N | N | N | N | Note 1, 2, 4,6, |
| Abdominal | N | N | N | N | N | N | N | Note 1, 2, 4,6, |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | | | | | | | | |
| Small organ(specify)** | | | | | | | | |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Trans-rectal | | | | | | | | |
| Trans-vaginal | | | | | | | | |
| 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 | N | N | N | N | N | N | N | 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. | | | | | | | | |
| **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 | | | | | | | | |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | | | | | | | | |
| | Mode of Operation | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | | | | | | | | |
| Fetal | | | | | | | | |
| Abdominal | N | N | N | | N | N | N | Note 1, 2, 4,6,7 |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | N | N | N | | N | N | N | Note 1, 2, 4,6,7 |
| Small organ(specify)** | | | | | | | | |
| Neonatal Cephalic | N | N | N | | N | N | N | Note 1, 2, 4,6,7 |
| Adult Cephalic | | | | | | | | |
| Trans-rectal | | | | | | | | |
| Trans-vaginal | | | | | | | | |
| Trans-urethral | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | |
| Intravascular | | | | | | | | |
| Cardiac Adult | N | N | N | | N | N | N | Note 1, 2, 4,6,7 |
| Cardiac Pediatric | N | N | N | | N | N | N | Note 1, 2, 4,6,7 |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | |
| Peripheral Vascular | N | N | N | | N | N | N | Note 1, 2, 4,6,7 |
| Other (specify)*** | | | | | | | | |

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

ElOK

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)

Mary S. Pastl

and Safety

•
•

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DC-T6 Diagnostic Ultrasound System

Transducer:

System:

Prescription USE (Per 21 CFR 801.109)

610K

:

Mary S. Patil

Division of Ra Office of In Vitr and Salety

**008-3**

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DC-T6 Diagnostic Ultrasound System

C5-2

Transducer: Intended Use:

System:

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

Prescription USE (Per 21 CFR 801.109)

510K

Concurrence of CDRH, Office of Device Evaluation(ODE)

Mina S Patil

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

.008-4

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

DC-T6 Diagnostic Ultrasound System

System: Transducer: Intended Use:

6C2

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

Prescription USE (Per 21 CFR 801.109)

EIOK

ﺑ

Moira S. Patel
(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Division of Rudiological Bovice Evaluation and Safety

008-5

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

DC-T6 Diagnostic Ultrasound System

V10-4

Transducer: Intended Use:

System:

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

| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|----------------------|-----------------------|------------------|--|--|--|
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | N | N | N | | N | ನಿ | N | Note 1, 2, 4,6,7 | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (specify)* | | | | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small organ(specify)** | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Trans-rectal | N | N | N | | N | N | N | Note 1, 2, 4,6,7 | | | |
| Trans-vaginal | N | N | N | | N | પિ | હ | Note 1, 2, 4,6,7 | | | |
| Trans-urethral | | | | | | | | | | | |
| Frans-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) ** * | ਮ | 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, 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 | | | | | | | | | | | |
| (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)

Mary S. Piatel

lon Sign-Off Division of Radiological Devices Office of In Vitro Diagnostic Dev Evaluation and Safety

510K. K110199

008-6

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System: Transducer: Intended Use: DC-T6 Diagnostic Ultrasound System V10-4B

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

| | Mode of Operation | | | | | | | |
|--------------------------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|----------------------|-----------------------|------------------|
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | | | | | | | | |
| Fetal | N | N | N | | N | N | N | Note 1, 2, 4,6,7 |
| Abdominal | | | | | | | | |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | | | | | | | | |
| Small organ(specify)** | | | | | | | | |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Trans-rectal | N | N | N | | N | N | N | Note 1, 2, 4,6,7 |
| Trans-vaginal | N | N | N | | N | N | N | 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. | | | | | | | | |
| ** 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 | | | | | | | | |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | | | | | | | | |
| | | | | | | | | |

Concurrence of CDRH, Office of Device Evaluation(ODE)

elok

Prescription USE (Per 21 CFR 801.109)

Mai S. Patel
(Division Sign-Off)

Office of In Vitro Diag

008-7

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

DC-T6 Diagnostic Ultrasound System

1.7-3

System: Transducer:

Intended Use:

.

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

| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) |
|--------------------------------------------------------------------------------------------------|---|---|-----|-----|---------------|-------------------|--------------------|-----------------|
| Ophthalmic | | | | | | | | |
| Fetal | | | | | | | | |
| Abdominal | N | N | N | | N | N | N | Note 1,2, 4,6,7 |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | N | N | N | | N | N | N | Note 1,2, 4,6,7 |
| Small organ (specify) ** | N | N | N | | N | N | N | Note 1,2, 4,6,7 |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Trans-rectal | | | | | | | | |
| Trans-vaginal | | | | | | | | |
| 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 | N | N | N | | N | N | N | Note 1,2, 4,6,7 |
| Other (specify) *** | | | | | | | | |
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | | | | | | | | |
| Additional comments: Combined modes: B+M, PW+B, Color + B, Power + B, PW+Color+ B, Power + PW+B. | | | | | | | | |
| * Intraoperative includes abdominal, thoracic, and vascular. | | | | | | | | |
| ** 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 | | | | | | | | |
| (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)

elok

Miny Slated
(Division Sign-Off)

(Divis 00 5 Division of Madiological Devices ice Evaluation and Safety Office of In Vitro Di

**008-8**

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

DC-T6 Diagnostic Ultrasound System

7L4A

Intended Use:

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

| | Mode of Operation | | | | | | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|----------------------|-----------------------|-----------------|
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | | | | | | | | |
| Fetal | | | | | | | | |
| Abdominal | N | N | N | | N | N | N | Note 1,2, 4,6,7 |
| Intraoperative (specify)* | | | | | | |…