DC-T6 DIAGNOSTIC ULTRASOUND SYSTEM

K120699 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · IYN · Apr 19, 2012 · Radiology

Device Facts

• Record ID: K120699
• Device Name: DC-T6 DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Apr 19, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The 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 vessel, urology and intraoperative (abdominal, thoracic, vascular) exams.

Device Story

Portable/mobile ultrasound system; acquires/displays images in B-Mode, M-Mode, CW-Mode, Color-Mode, Color M-Mode, Power/Dirpower Mode, TDI mode, 3D/4D, and combined modes. Employs linear, convex, and phased array probes (2.5-10.0 MHz). Used in clinical settings by healthcare professionals. System processes acoustic signals to generate diagnostic images; supports features like Tissue Harmonic Imaging, Smart3D, 4D, iScape, TDI, and biopsy guidance. Output viewed by clinicians to assist in diagnosis and patient management across various anatomical regions.

Clinical Evidence

Bench testing only. Device 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 series, IEC 60601-2-37, UL 60601-1, ISO 14971, and IEC 62304.

Technological Characteristics

Portable/mobile ultrasound system; supports linear, convex, and phased array transducers (2.5-10.0 MHz). Operating modes: B, M, CW, Color, Power/Dirpower, TDI, 3D/4D. Features: Tissue Harmonic Imaging, Smart3D, iScape. Conforms to IEC 60601-1, IEC 60601-2-37, and ISO 14971. Software-controlled.

Indications for Use

Indicated for adults, pregnant women, pediatric patients, and neonates for fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal/adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal, cardiac, peripheral vessel, urology, and intraoperative 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 DC-T6 (K110199)
• Mindray DC-7/M7/DC-8 (K103583/K103677/K113647)
• Philips iU22 Diagnostic Ultrasound System (K093563)

Submission Summary (Full Text)

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# 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92(c).

The assigned 510(k) number is: K/20699

### 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:

Wu zicui

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

Date Prepared: January 31th, 2012

#### 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 (IYN)

21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (IYO)

21 CFR 892.1570 Diagnostic Ultrasound Transducer (ITX)

#### 3. Device Description:

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

B-1

{1}------------------------------------------------

Color M-Mode, Power/Dirpower Mode, TDI mode, 3D/4D 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 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 vessel, urology and intraoperative (abdominal, thoracic, vascular) exams.

#### 5. Comparison with Predicate Device:

DC-T6 Diagnostic Ultrasound System is already cleared under premarket notification number K110199. The new feature is comparable with and substantially equivalent to the Mindray DC-7/ M7/ DC-8 Diagnostic Ultrasound System that are already cleared under premarket notification number K103583/K103677/ K113647 and Philips iU22 Diagnostic Ultraound System under premarket notification number K093563. They have the same technological characteristics, are comparable in key safety and effectiveness features, and have the same intended uses and basic operating modes as the predicate device.

#### 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, 1EC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-37, UL 60601-1, ISO14971 and IEC 62304.

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

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

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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, LLC 12 Laboratory Drive RESEARCH TRIANBLE PARK NC 27709

APR 1 9 2012

Re: K120699

Trade/Device Name: The 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: April 5, 2012 Received: April 12, 2012

Dear Mr. Rongero:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for I ins uttentimation of ourseand System, as described in your premarket notification:

| | Transducer Model Number | |
|--------|-------------------------|--------|
| 3C5A | L11-4 | P7-3 |
| C5-2 | L12-4 | L14-6N |
| 6C2 | 7L5 | CB10-4 |
| V10-4 | L14-6 | 7LT4 |
| V10-4B | P4-2 | CW5s |
| L7-3 | 2P2 | |
| 7L4A | 4CD4 | |

{3}------------------------------------------------

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 Jeffrey Ballyns at [phone].

Sincerely Yours,

1111111

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

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

## Indications for Use

510(k) Number (if known):

Device Name: The DC-T6 Diagnostic Ultrasound System

Indications for Use:

510K

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, cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), cardiac (adult, pediatric), peripheral vessel, urology and intraoperative (abdominal, thoracic, vascular) exams.

Over - The - Counter Use Prescription Use X AND/OR (21 CFR Part 807 Subpart (21 CFR Part 801 Subpart D) C)

(Please Do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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

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| System | | | | Transducer | | × | | |
|-----------------------------------------------------------------------------------------------------|---|---|------|------------|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|-------------------|
| Model: | | | P4-2 | | | | | |
| 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 | | | | | | | | |
| Abdominal | P | P | P | P | P | P | P | Note 1, 2,4,5,6,7 |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | Note 1, 2,4,5,6,7 |
| Small organ(specify)** | | | | | | | | |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | P | P | P | P | P | P | P | Note 1, 2,4,5,6,7 |
| Trans-rectal | | | | | | | | |
| Trans-vaginal | | | | | | | | |
| Trans-urethral | | | | | | | | |
| Trans-esoph.(non-Card.)<br>TATURANDOEZKEINERI | | | | | | | | |
| antiana<br>Musculo-skeletal Superficial | | | | | | | | |
| Intravascular | | | | | | | | |
| Cardiac Adult | P | P | P | P | P | P | P | Note 1, 2,4,5,6,7 |
| Cardiac Pediatric | P | P | P | P | P | P | P | Note 1, 2,4,5,6,7 |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | |
| Peripheral Vascular | | | | | | | | |
| Other (specify) *** | | | | | | | | |
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | | | | | | | | |
| Additional comments: Combined modes: B+M, PW+B, Color + B, PW +Color+B, PW +Color+B, Power + PW +B, | | | | | | | | |
| * Intraoperative includes abdominal, thoracic, and vascular 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 | | | | | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | |
| NoteS: TDI | | | | | | . 11 September 19 March 2017 - 1 September 2017 - 1 Marie 2017 - 1 Marie 2017 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 | | |
| 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)

Samual Morris
(Division/Sign-Off)

510K

(Division of Radiological Devices Office of in Vita of Haulotogical Device Evaluation and Safety

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

| System | | Transducer | X |
|------------------|-------|------------|---|
| Model: | L14-6 | | |
| 510(k) Number(s) | | | |

Diagnostic Ultrasound Indications for Use Form

| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (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 | 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 | 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 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 CDBH. Office of Device Evaluation(ODE)

.

:

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. K120699

{7}------------------------------------------------

Transducer

System Model:

DC-T6

×

510(k) Number(s)

| 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 | P | Note1,2, 3, 4,6,7 |
| Abdominal | P | P | P | P | P | P | P | Note1,2, 3, 4,5,6,7 |
| Intraoperative (specify)* | N | N | N | | N | N | N | Note 1,2,4,6,7 |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | Note 1, 2, 4,5,6,7 |
| Small organ(specify)** | P | P | P | P | P | P | P | Note1, 2, 4,6,7 |
| Neonatal Cephalic | P | P | P | P | P | P | P | Note1, 2, 4,5,6,7 |
| Adult Cephalic | P | P | P | P | P | P | P | Note1, 2, 4,5,6,7 |
| 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 | 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 | 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 | Note 1,2,4,6,7 |
| Other (specify)*** | P | P | P | | P | P | P | 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)

Janne Horris

(Division of Radiological Devices
Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Device Evaluation and Safs:

510K. K1206.99

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

| System | | | | Transducer | X | | | |
|------------------|------|--|--|------------|---|--|--|--|
| Model: | 3C5A | | | | | | | |
| 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 | P | P | P | | P | P | P | Note 1, 2, 4,6,7 |
| 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 Superficial | | | | | | | | |
| Intravascular | | | | | | | | |
| Cardiac Adult | | | | | | | | |
| Cardiac Pediatric | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | Note 1, 2, 4,6,7 |
| 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 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)

Laune Morris
(Division Sign-Off)

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

610K.

5120699

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

**Diagnostic Ultrasound Indications for Use Form**

| System | |
|------------------|------|
| Model: | C5-2 |
| 510(k) Number(s) | |

| Transducer | X |
|------------|---|
|------------|---|

| 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 | P | P | P | | P | P | P | Note 1, 2, 4,6,7 |
| 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 Superficial | | | | | | | | |
| Intravascular. | | | | | | | | |
| Cardiac Adult | | | | | | | | |
| Cardiac Pediatric | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | Note 1, 2, 4,6,7 |
| 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 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)

Prescription 510-(K-12)

(Division Sign-Off)
Division of Radiological Devices

Office of In Vitro Diagnostic Device Evaluation and Safety

.

.

510K.

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

| System | |
|------------------|-----|
| Transducer | X |
| Model: | 6C2 |
| 510(k) Number(s) | |

| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (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 | | | | | | | | |
| Trans-rectal | | | | | | | | |
| Trans-vaginal | | | | | | | | |
| Trans-urethral | | | | | | | | |
| Trans-esoph.(non-Card.) | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | |
| Intravascular | | | | | | | | |
| Cardiac Adult | P | P | P | | P | P | P | Note 1, 2, 4,6,7 |
| Cardiac Pediatric | P | P | P | | P | P | P | Note 1, 2, 4,6,7 |
| 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, 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 Raciological Devices
Diffice of to Vitto Discion of Raciological Devices
Office of to Vitto Diegnostic Devices Evaluetion and Safety

610K Kia0699

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

| System | | Transducer | X |
|------------------|-------|------------|---|
| Model: | V10-4 | | |
| 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 | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | |
| Intravascular | | | | | | | | |
| Cardiac Adult | | | | | | | | |
| Cardiac Pediatric | | | 4 | | | | | |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph (Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | |
| Peripheral Vascular | | | | | | | | |
| Other (specify)*** | P | P | P | | P | P | P | 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)

.

Diagnostic Ultrasound Indications for Use Form

.

・

Prescription USE (Per 21 CFR 801.109)

'

Hause Hause
(Division Sign-Off)

Division of Rac ologics! Devices Office of the tion and Safety

RIOK

. .

the

008-6

.

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

| 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 Superficial | | | | | | | | |
| Intravascular | | | | | | | | |
| Cardiac Adult | | | | | | | | |
| Cardiac Pediatric | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph.(Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | |
| Peripheral Vascular | | | | | | | | |
| Other (specify)*** | P | P | P | | P | P | P | 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, 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

Concurrence of CDRH, Office of Device Evaluation(ODE)

·

Prescription USE (Per 21 CFR 801.109)

Hanne Thuris
(Division Sign-Off)
Division of Radiological Devices

Division of Radfological Devices Office of In Vitro Diegnostic Device Evaluation and Safety

510K.

:

.

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

| System | | | | Transducer | | X | | |
|------------------|--|--|------|------------|--|---|--|--|
| Model: | | | L7-3 | | | | | |
| 510(k) Number(s) | | | | | | | | |

| | Mode of Operation | | | | | | | |
|------------------------------|-------------------|---|-----|-----|---------------|-------------------|--------------------|-----------------|
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (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 | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Trans-rectal | | | | | | | | |
| Trans-vaginal | | | | | | | | |
| Trans-urethral | | | | | | | | |
| Trans-esoph.(non-Card.) | | | | | | | | |
| Musculo-skeletal | | | | | | | | |
| 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, 4,6,7 |
| 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 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)

.

Laurence Masters
(Division Sign-Off)

(Division of Badiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

810K

008-8

:

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

| System | | | | Transducer | | × | | | | |
|-------------------------------------------------------------------------------------------------|-------------------|-----------------------|-----------------|------------|---------|---------|-----------|-----------------|--|--|
| Model: | | | 7L4A | | | | | | | |
| 510(k) Number(s) | | | | | | | | | | |
| | | | | | | | | | | |
| | Mode of Operation | | | | | | | | | |
| Clinical Application | B | Combined<br>Amplitude | Other (specify) | | | | | | | |
| | | M | PWD | CWD | Doppler | Doppler | (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.) | | | | | | | | | | |
| TATUSQUID=2KCISIST | 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 | | | | | | | | | | |
| NoteS: TDI | | | | | | | | | | |
| Note6: Color M | | | | | | | | | | |
| Note7: Biopsy Guidance | | | | | | | | | | |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | | | | | | | | | | |

Prescription USE (Per 21 CFR 801.109)

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

510K. .

:" " "

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

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

| System | | | | Transducer | | X | | |
|------------------------------------------------------------------------------------------------|---|---|-------|------------|-------------------|----------------------|-----------------------|-----------------|
| Model: | | | L11-4 | | | | | |
| 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 | | | | | | | | |
| 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…