DC-8/DC-8 PRO/DC-8, CV/DC-8, EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM

K123185 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · IYO · Nov 2, 2012 · Radiology

Device Facts

• Record ID: K123185
• Device Name: DC-8/DC-8 PRO/DC-8, CV/DC-8, EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: IYO · Radiology
• Decision Date: Nov 2, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S 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, cardiac pediatric, peripheral vessel and urology exams.

Device Story

Mobile, software-controlled diagnostic ultrasound system; acquires/displays images in B-Mode, M-Mode, PW-Mode, CW-Mode, Color-Mode, Color M-Mode, Power/Dirpower Mode, TDI, 3D/4D, and Elastography. Employs linear, convex, and phased array probes (3-10 MHz). Used in clinical settings by healthcare professionals for diagnostic imaging and fluid flow analysis. System processes ultrasound signals to generate real-time images; supports combined modes (e.g., B+M, PW+B). Output assists clinicians in anatomical visualization, biopsy guidance, and physiological assessment, aiding clinical decision-making and patient diagnosis.

Clinical Evidence

Bench testing only. Evaluated for acoustic output, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, and mechanical safety. Conforms to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, IEC 62366, and ISO 10993-1 standards.

Technological Characteristics

Mobile ultrasound system; linear, convex, phased array transducers (3-10 MHz). Modes: B, M, PW, CW, Color, Power/Dirpower, TDI, 3D/4D, Elastography. Software-controlled. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, IEC 62366, ISO 14971, ISO 10993-1, UL 60601-1. Biocompatible materials.

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, and urology exams.

Regulatory Classification

Identification

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• DC-8/DC-8PRO/DC-8 CV/DC-8 EXP/DC-8S (K113647)
• DC-7 (K103583, K101041)
• DC-T6 (K110199)
• Z6 (K122010)
• ACUSON S2000 (K112596)
• SONOLINE Antares Ultrasound Imaging System (K050034)

Submission Summary (Full Text)

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# 510(K) SUMMARY

........ 3 | ................................................................................................................................................................. NOV

2 7.1112

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/23/85

## 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: August 28, 2012

#### 2. Device Name: DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S 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 (90-1YO) 21 CFR 892.1570 Diagnostic Ultrasound Transducer (90-ITX)

### 3. Device Description:

DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S 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, 3D/4D mode,

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Elastography 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 3 MHz to 10.0 MHz.

### 4. Intended Use:

The DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S 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, cardiac pediatric, peripheral vessel and urology exams.

#### 5. Comparison with Predicate Devices:

DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices:

| Predicate<br>Device | Manufacturer | Model | 510(k) Number |
|---------------------|--------------|--------------------------------------------------|--------------------|
| 1 | Mindray | DC-8/DC-8PRO/DC-8 CV<br>/DC-8 EXP/DC-8S | K113647 |
| 2 | Mindray | DC-7 | K103583<br>K101041 |
| 3 | Mindray | DC-T6 | K110199 |
| 4 | Mindray | Z6 | K122010 |
| 5 | SIEMENS | ACUSON S2000 | K112596 |
| 6 | SIEMENS | SONOLINE Antares<br>Ultrasound Imaging<br>System | K050034 |

They have the similar 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-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S 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: IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC

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60601-2-37, IEC 62304, IEC 62366,UL 60601-1, ISO14971, UD 2, UD 3 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-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

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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 features a stylized eagle with three stripes extending from its head, representing health, science, and human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

MAR 2 1 2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Mr. Jeff D. Rongero Senior Project Engineer Underwriters Laboratories, Inc. l 2 Laboratory Drive Research Triangle Park, NC 27709

Re: K123185

Trade/Device Name: DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYO. IYN, and ITX Dated: September 27, 2012 Received: September 10, 2012

Dear Mr. Rongero:

This letter corrects our substantially equivalent letter of November 2, 2012.

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

This determination of substantial equivalence applies to the following transducers intended for use with the DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System, as described in your premarket notification:

#### Transducer Model Number

| C5-2E | D8-3E |
|---------|---------|
| C7-3E | V11-3E |
| L12-3E | C11-3E |
| L14-6NE | DE10-3E |
| L14-6WE | V11-3BE |
| P4-2E | V11-3WE |
| D6-2E | L7-3E |

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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 Ms. Lauren Hefner at [phone].

Sincerely Yours,

Narkin D'Ohm for

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

Enclosure(s)

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# Indications for Use

### 510(k) Number (if known):

# Device Name: DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System

#### Indications For Use:

The DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S 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-ട്ടിലെന്നും വാഹ്യമാന്ത്രി vessel and urology exams.

23185

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

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

1 Page 1 of *1*

(Division Sign Off

Division of Radiological He

Radiological Health Office of in Vitro Diagnostic

51006 K122185

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| System: | DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System | | | | | | | | | |
|-----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|----|-------------------|-----|--------------------------|------------------|----------------------|-----------------------|----------------------|--|
| Transducer. | N/A | | | | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
| Clinical Application | Mode of Operation | | | | | | | | | |
| General (Track I Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | P | P | P | | P | P | P | Note 1, 2,3, 4,6,7 | |
| | Abdominal. | P | P | P | P | P | P | P | Note 1, 2,3, 4,5,6,7 | |
| | Intra-operative (Specify*) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | P | P | P | P | P | P | P | Note 1, 2,3, 4,5,6,7 | |
| | Small Organ (Specify**) | P | P | P | | P | P | P | Note 1,2, 4,6,7,8 | |
| Fetal Imaging & | Neonatal Cephalic | P | P | P | P | P | P | P | Note 1, 2,4,5,6,7 | |
| Other | Adult Cephalic | P | P | P | P | P | P | P | Note 1, 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 (Conventional) | 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, 2,4,5,6,7 | |
| | Cardiac Pediatric | P | P | P | P | P | P | P | Note 1, 2,4,5,6,7 | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| Peripheral | Peripheral vessel | P | P | P | | P | P | P | Note 1, 2, 4,6,7 | |
| vessel | 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. | | | | | | | | | |
| | **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 | | | | | | | | | |
| | Note8: Elastography | | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | | |
| Clinical Application | | | Mode of Operation | | | | | | | |
| General (Track<br>1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) | |
| Ophthalmic | 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 | |
| | Intra-operative (Specify®) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Podiatric | P | P | P | | P | P | P | Note 1, 2, 4,6,7 | |
| | Small Organ (Specify®*) | | | | | | | | | |
| | Fetal Imaging & Neonatal Cephalic | | | | | | | | | |
| Other | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal (Conventional) | p | P | P | | P | P | p | Note 1, 2, 4,6,7 | |
| | Musculo-skeletal (Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| Peripheral | Peripheral vessel | P | P | P | | P | P | P | Note 1, 2, 4,6,7 | |
| vessel | Other (Specify® ** ) | | | | | | | | | |
| | N=new indication; P=previously cleared by FDA: | | | | Evadded under Appendix E | | | | | |
| | Additional comments: Combined modes-BitM. PW+B、Color + B. Power + B. PW +Color+ B. Power + PW+B. | | | | | | | | | |
| | · Intraoperative includes abdominal, thoracic, and vascular. | | | | | | | | | |
| | ** Small organ-breast, thyroid, testes.<br>*** Other use includes Urology. | | | | | | | | | |
| | Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | | |
| | Note 2: Sman3D | | | | | | | | | |
| | Note 3:4D(Real-time 3D) | | | | | | | | | |
| | Note 4: iScape | | | | | | | | | |
| Note5: TDI | | | | | | | | | | |
| | Note6: Color M | | | | | | | | | |
| | Note7: Biopsy Guidance | | | | | | | | | |
| Note8: Elastography | | | | | | | | | | |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | | | |
| Concurrence of CDRH, Office of Device Evaluation(ODE) | | | | | | | | | | |
| | 49.00<br>Thus | | | | | | | | | |
| Clinical Application | | | Mode of Operation | | | | | | | |
| General (Track<br>1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) | |
| Ophthalmic | 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 | |
| | Intra-operative (Specify*) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | Note 1, 2, 4,6,7 | |
| | Small Organ (Specify**) | | | | | | | | | |
| Fetal Imaging & | Neonatal Cephalic | | | | | | | | | |
| Other | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal (Conventional) | | | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| Peripheral | Peripheral vessel | P | P | P | | P | P | P | Note 1, 2, 4,6,7 | |
| vessel | 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 | | | | | | | | | |

### Diagnostic Ultrasound Indications For Use Format

008-2

Office of In Vitro Diagnostics and Radiological Health

510(k) K123185

(Division Sign Off) Division of Radiological Health

ﻴﺔ

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DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System System:

C5-2E Transducer:

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

Division of Radiological Health

Office of In Vitro Diagnostics and Radiological Hesith

彩 .

5100d K123185

**008-3**

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System:

#### DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System

·Transducer: C7-3E

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

NoteS: TDI

Note6: Color M Note7: Biopsy Guidance

Note8: Elastography

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

Michael D'Kunn
(Division Sign Off)

Division of Radiological Health

Office of In Vitro Diagnostics and Radiological Health

51000 K123185

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#### DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System System:

LI2-3E Transducer:

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

| Clinical Application | | Mode of Operation | | | | | | | |
|---------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------|---|-----|--------------------------|------------------|----------------------|-----------------------|-------------------|
| General (Track<br>1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| | Abdominal | P | P | P | | P | P | P | Note 1, 2, 4,6,7 |
| | Intra-operative (Specify*) | | | | | | | | |
| | Intra-operative (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, 4,6,7,8 |
| Fetal Imaging &<br>Other | 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 (Conventional) | 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 | | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | 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. | | | | | | | | | |
| ** Small organ-breast, thyroid, testes.<br>***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 Note8: Elastography

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

(Div n Sian

Division of Radiological Health

Office of In Vitro Diagnostics and Radiological Health

51004 K123185

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

| Transducer: | L14-6NE | | | | | | | | | |
|--------------------------|------------------------------------------------------------------------------------------|-------------------|---|-----|-----|---------------|-------------------|--------------------|-------------------|--|
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
| | Clinical Application | Mode of Operation | | | | | | | | |
| General (Track I Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | | | | | | | | | |
| | Abdominal | P | P | P | | P | P | P | Note 1,2, 4,6,7 | |
| | Intra-operative (Specify*) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| Fetal Imaging &<br>Other | 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, 4,6,7,8 | |
| | 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 (Conventional) | 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 | |
| Cardiac | Intravascular | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | 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. | | | | | | | | | |
| | **Small organ-breast, thyroid, testes. | | | | | | | | | |
| | ***Other use includes Urology. | | | | | | | | | |

DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System System:

> Note 2: Smart3D Note 3:4D(Real-time 3D) Note 4: iScape

NoteS: TDI

Note6: Color M Note7: Biopsy Guidance

Note8: Elastography

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

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

(Division Sign Off)

Division of Radiological Health

Office of In Vitro Diagnostics and Radiological Health

5100d K12318S

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

DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System System:

LI4-6WE Transducer:

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

| Clinical Application | | Mode of Operation | | | | | | | |
|-------------------------------------------------------------------------------------------------|---------------------------------|-------------------|---|-----|-----|---------------|-------------------|--------------------|-------------------|
| General (Track 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| | Abdominal | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| | Intra-operative (Specify*) | | | | | | | | |
| | Intra-operative (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, 4,6,7,8 |
| Fetal Imaging &<br>Other | 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 (Conventional) | 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 | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | 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. | | | | | | | | | |
| **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 | | | | | | | | | |
| Note8: Elastography | | | | | | | | | |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)…