DC-N3/DC-NS3 DIAGNOSTIC ULTRASOUND SYSTEM

K123503 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · IYN · Dec 13, 2012 · Radiology

Device Facts

• Record ID: K123503
• Device Name: DC-N3/DC-NS3 DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Dec 13, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

DC-N3/DC-N3S Diagnostic Ultrasound System is applicable for adult, pregnant woman, pediatric and neonate. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes.), cephalic(neonatal and adult), trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), cardiac(Adult and Pediatric), Peripheral Vascular and urology exams.

Device Story

Mobile, software-controlled diagnostic ultrasound system; acquires/displays ultrasound data in B, M, PW, CW, Color, Power, HPRF, TVI, TEI, TVD, Free Xros M/CM, Smart 3D, 4D, and iScape modes. Uses linear, convex, and phased array probes (2.5–10.0 MHz). Operated by clinicians in clinical settings. System processes acoustic signals to generate real-time images for diagnostic visualization. Output assists clinicians in anatomical assessment, biopsy guidance, and clinical decision-making across various patient populations. Benefits include non-invasive diagnostic imaging for diverse clinical applications.

Clinical Evidence

Bench testing only. Evaluated for acoustic output, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, and mechanical safety. Conforms to standards including IEC 60601-1, IEC 60601-2-37, ISO 14971, and ISO 10993-1.

Technological Characteristics

Mobile ultrasound system; linear, convex, and phased array transducers (2.5–10.0 MHz). Modes: B, M, PW, CW, Color, Power, HPRF, TVI, TEI, TVD, Free Xros M/CM, Smart 3D, 4D, iScape. Standards: IEC 60601-1, IEC 60601-2-37, ISO 10993-1, ISO 14971. Software-controlled.

Indications for Use

Indicated for adults, pregnant women, pediatric patients, and neonates. Applications include fetal, abdominal, pediatric, small organ (breast, thyroid, testes), cephalic (neonatal/adult), trans-rectal, trans-vaginal, musculo-skeletal (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 DC-7 (K103583)
• Mindray DC-T6 (K120699)
• Mindray DC-8 (K113647)
• Mindray Z6 (K122010)

Submission Summary (Full Text)

{0}------------------------------------------------

K123503

# 510(K) SUMMARY

# DEC 1 3 2012

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:

Bai Yanhong 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: September 7, 2012

## 2. Device Name: DC-N3/DC-N3S Diagnostic Ultrasound System

#### Classification

Regulatory Class: II

Review Category: Tier II

21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System (90-IYN)

21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (90-IYO)

21 CFR 892.1570 Diagnostic Ultrasound Transducer (90-ITX)

## 3. Device Description:

DC-N3/DC-N3S is a mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B, M, PW, CW, Color, Power, HPRF, TVI, TEI,TVD, Free Xros M/ Free Xros CM, Smart 3D, 4D, iScape, or the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color).This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased

Image /page/0/Figure/20 description: The image shows the number 05-1 in bold black font. The number 05 is followed by a hyphen and then the number 1. The background is white.

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

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

# 4. Intended Use:

DC-N3/DC-N3S Diagnostic Ultrasound System is applicable for adult, pregnant woman, pediatric and neonate. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes.), cephalic(neonatal and adult), trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), cardiac(Adult and Pediatric), Peripheral Vascular and urology exams.

# 5. Comparison with Predicate Devices:

| Predicate<br>Device | Manufacturer | Model | 510(k) Control Number |
|---------------------|--------------|-------|-----------------------|
| 1 | Mindray | DC-7 | K103583 |
| 2 | Mindray | DC-T6 | K120699 |
| 3 | Mindray | DC-8 | K113647 |
| 4 | Mindray | Z6 | K122010 |

DC-N3/DC-N3S Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices:

They have the same technological characteristics, are comparable in key safety and effectiveness features, and have the same intended uses and basic operating modes as the predicate devices.

# 6. Non-clinical Tests:

DC-N3/DC-N3S 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 safety standards. Therefore, the DC-N3/DC-N3S Diagnostic Ultrasound System is

Image /page/1/Figure/11 description: The image shows the number "05-2" in a bold, sans-serif font. The numbers and hyphen are all in black. The background is white.

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

substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

.

:

.

.

.

**05-3**

:

:

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

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a human figure embracing a globe.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 13, 2012

Shenzhen Mindray Bio-Medical Electronics., Ltd. . % Mr. Jeff D. Rongero Senior Project Engineer Underwriters Laboratories, Inc. 12 Laboratory Drive Research Triangle Park, NC 27709

> 3C5A 6C2 V10-4 V10-4B 7L4A L12-4

Re: K123503

Trade/Device Name: The DC-N3/DC-N3S 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: October 31, 2012 Received: November 13, 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 use with the The DC-N3/DC-N3S Diagnostic Ultrasound System as described in your premarket notification:

#### Transducer Model Number

| | L14-6 |
|--|-------|
| | 2P2 |
| | D6-2 |
| | D6-2A |
| | 6CV1 |

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 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/ReportalProblem/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 Lauren Hefner at [phone].

Sincerely Yours.

# Janine M. Morris -S

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure(s)

{5}------------------------------------------------

# Indications for Use

510(k) Number (if known):

Device Name: The DC-N3/ DC-N3S Diagnostic Ultrasound System

Indications for Use:

The DC-N3/ DC-N3S 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), cephalic (neonatal and adult), trans-rectal, trans-vaginal, musculo-skeletal (conventional and superficial), cardiac (adult and pediatric), peripheral vascular and urology exams.

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

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

Concurrence of CDRH, Office of In Vitro Diagnostic and Radiological Health (OIR)

ivision of Rediolor

Office of In Vitro Diagnostics

510(k) K123503

**OS-1**

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

Transducer

______________________________________________________________________________________________________________________________________________________________________________

and the same of the same of the states of the states of the states of the states of the states of the states of the states of the states of the states of the states of the st

System Model:

DC-N3

×

.

510(k) Number(s)

| | Mode of Operation | | | | | | | |
|---------------------------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|------------------------|-----------------------|---------------------|
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>e Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | | | | | | | | |
| Fetal | N | N | N | N | N | N | N | Note1,2, 3, 4,6,7 |
| Abdominal | N | N | N | N | N | N | N | Note1,2, 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 | Note1, 2, 4,6,7 |
| Neonatal Cephalic | N | N | N | N | N | N | N | Note1, 2, 4,5,6,7 |
| Adult Cephalic | N | N | N | N | N | N | N | Note1, 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 | 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 |
| 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) | | | | | | | | |

Biriston of Radiolog

510(k)

**08-2**

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

| System | | | | Transducer | | X | | | | |
|---------------------------------------------------------------------------------------------------|-------------------|---|------|------------|------------------|-----------------------|-----------------------|------------------|--|--|
| Model: | | | 3C5A | | | | | | | |
| 510(k) Number(s) | | | | | | | | | | |
| | | | | | | | | | | |
| | Mode of Operation | | | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitud<br>e Doppler | Combined<br>(specify) | Other (specify) | | |
| Ophthalmic | | | | | | | | | | |
| Fetal | N | N | N | | N | N | N | Note 1, 2, 4,6,7 | | |
| 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 | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Trans-esoph (non-Card.) | | | | | | | | | | |
| Musculo-skeletal | N | N | N | | N | N | N | Note 1, 2, 4,6,7 | | |
| 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 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) | | | | | | | | | | |

Division of Radiological Health

Office of In Vitro Diagnostics and Radiological Health

ID+

Prescription USE (Per 21 CFR 801.109)

ン... ・

510(k) K123503

**08-3**

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

6C2

×

System Model:

510(k) Number(s)

| | Mode of Operation | | | | | | | |
|---------------------------------------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|------------------------|-----------------------|------------------|
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>e Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | | | | | | | | |
| Fetal | | | | | | | | |
| Abdominal | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 |
| Small organ(specify)** | | | | | | | | |
| Neonatal Cephalic | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 |
| Adult Cephalic | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 |
| Trans-rectal | | | | | | | | |
| Trans-vaginal | | | | | | | | |
| Trans-urethral | | | | | | | | |
| Trans-esoph.(non-Card.) | | | | | | | | |
| Musculo-skeletal | 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, 4,6,7 |
| Cardiac Pediatric | N | 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 | 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, 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) | | | | | | | | |
| | 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 | 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 | 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 | | | | | | | | |
| 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 | N | Note 1, 2, 4,6,7 |
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | | | | | | | | |
| Additional comments:Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B. | | | | | | | | |
| * Intraoperative includes abdominal, thoracic, and vascular etc. | | | | | | | | |
| ** Small organ-breast, thyroid, testes, etc. | | | | | | | | |
| *** Other use includes Urology. | | | | | | | | |
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | |
| Note 2: Smart3D | | | | | | | | |
| Note 3:4D(Real-time 3D) | | | | | | | | |
| Note 4: iScape | | | | | | | | |
| Note5: TDI | | | | | | | | |
| Note6: Color M | | | | | | | | |
| Note7: Biopsy Guidance | | | | | | | | |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | | | | | | | | |

Concurrence of CDRH, Office of Device Evaluation(QDE)

Prescription USE (Per 21 CFR 801.109)

(Division Sign Off)

Division of Radiological Health

510(k)

**08-4**

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

V 10-4

Transducer

×

System Mođel:

510(k) Number(s)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription USE (Per 21 CFR 80 1000

CFR 801(f)(9)
(Division Sign Off)

Division of Radiological Health

510(k) K123503

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

| 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 | 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 | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | |
| Intravascular | | | | | | | | |
| Cardiac Adult | | | | | | | | |
| Cardiac Pediatric | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph.(Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | |
| Peripheral Vascular | | | | | | | | |
| Other (specify) *** | N | N | N | | N | N | N | Note 1, 2, 4,6,7 |

N=new indication; P=previously cleared by FDA; E=added under Appendix E

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

* Intraoperative includes abdominal, thoracic, and vascular etc.

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

*** Other use includes Urology.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Smart3D

Note 3:4D(Real-time 3D)

Note 4: iScape

Note5: TDI

Note6: Color M

Note7: Biopsy Guidance

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

Concurrence of CDRH, Office of Device Evaluation(QDE)

Prescription USE (Per 21 CFR 801.189)

.

・

(Division Sign Off)

Division of Radiological Health

510(k) K123503

**08-6**

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

| Model: | | | 7L4A | | | | | |
|---------------------------------------------------------------------------------------------------|---|---|------|-----|-------------------|----------------------|-----------------------|-----------------|
| 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 | 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 | 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 | N | N | N | | N | N | N | Note 1,2, 4,6,7 |
| Musculo-skeletal Superficial | N | N | N | | N | N | N | Note 1,2, 4,6,7 |
| 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 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) | | | | | | | | |

Transducer

×

System

(Division Sign Off)

Prescription USE (Per 21 CFR 801.109)

Division of Rastiblogical Health

afte

Office of In Vitro Diagnostics and Radiological Health

510(k) K123503

1

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

______________________________________________________________________________________________________________________________________________________________________________

L12-4

x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x

System Model:

·

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 | N | N | N | N | N | N | N | Note 1,2, 4,6,7 |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | N | N | N | N | N | N | N | Note 1,2, 4,6,7 |
| 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, 4,6,7 |
| Adult Cephalic | | | | | | | | |
| Trans-rectal | | | | | | | | |
| Trans-vaginal | | | | | | | | |
| Trans-urethral | | | | | | | | |
| Trans-esoph.(non-Card.) | | | | | | | | |
| Musculo-skeletal | 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 | | | | | | | | |
| Cardiac Pediatric | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | |
| Peripheral Vascular | N | N | N | N | N | N | N | Note 1,2, 4,6,7 |
| Other (specify)*** | | | | | | | | |

(Division Sign Off) Division of Radiological Health

510(k) K123503

**08-8**

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

L 14-6

Transducer

.

×

System Model:

510(k) Number(s)

| | Mode of Operation | | | | | | | |
|----------------------------------------------------------------------------------------------------------------|-------------------|---------------------|-----|-----|------------------|------------------------|-----------------------|-------------------|
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>e Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | | | | | | | | |
| Fetal | | | | | | | | |
| Abdominal | N | N | N | N | N | N | N | Note 1,2, 4,6,7 |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | N | N | N | N | N | N | N | Note 1,2, 4,6,7 |
| 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, 4,6,7 |
| Adult Cephalic | | | | | | | | |
| Trans-rectal | | | | | | | | |
| Trans-vaginal | | | | | | | | |
| Trans-urethral | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | |
| Musculo-skeletal | 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 | | | | | | | | |
| Cardiac Pediatric | | | | | | | | |
| 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=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<br>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) | | | | | | |
| | Mode of Operation | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>e Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | | | | | | | | |
| Fetal | | | | | | | | |
| Abdominal | N | N | N | N | N | N | N | Note 1, 2,4,5,6,7 |
| Intraoperative (specify)*…