DC-8/ DC-8 PRO/ DC-8 CV/ DC-8 EXP/ DC-8S DIAGNOSTIC ULTRASOUND SYSTEMS

K132341 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · IYN · Aug 15, 2013 · Radiology

Device Facts

• Record ID: K132341
• Device Name: DC-8/ DC-8 PRO/ DC-8 CV/ DC-8 EXP/ DC-8S DIAGNOSTIC ULTRASOUND SYSTEMS
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Aug 15, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• 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, urology and transesophageal (Cardiac) exams.

Device Story

Mobile, software-controlled diagnostic ultrasound system; acquires/displays images in B, M, PW, CW, Color, Power/Dirpower, TDI, 3D/4D, and Elastography modes. Uses linear, convex, and phased array probes (3-10 MHz). Operated by clinicians in clinical settings. Transforms received ultrasonic echoes into anatomical/fluid flow displays; supports specialized measurements/calculations. New features include LVO, Smart Volume, Smart NT, Stress Echo, Tissue Tracking QA, UltraView, Strain, Strain Rate, Color STIC, HR Flow, Color Smart 3D, and Echo Boost. Output viewed on-screen to assist in diagnosis and clinical decision-making; benefits include non-invasive visualization of internal structures and blood flow.

Clinical Evidence

No clinical data. Substantial equivalence determined via bench testing, including acoustic output measurement, biocompatibility, cleaning/disinfection effectiveness, and thermal/electrical/mechanical safety testing per AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, and ISO 10993-1.

Technological Characteristics

Mobile ultrasound system; linear, convex, and phased array transducers (3-10 MHz). Modes: B, M, PW, CW, Color, Power, TDI, 3D/4D, Elastography. Connectivity: Standard ultrasound interfaces. Safety: IEC 60601-1, IEC 60601-2-37, ISO 10993-1. Software: IEC 62304 compliant.

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 (adult/pediatric/transesophageal), peripheral vessel, 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

• DC-8 (K123185)
• M7 (K121010)
• DC-T6 (K120699)
• Vivid E9 (K120201)
• ACUSON S2000 (K112596)
• Voluson E8 (K101236)

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.

The assigned 510(k) number is: K132341 .

### 1. Submitter:

**AUG 15 2013**

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: May 22, 2013

Device Name: DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic 2.

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-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, CNV mode, Color-mode, Color m-Mode, Power/Dirpower mode, TDI mode, 3D/4D mode,

Page 1 of 4

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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, urology and transesophageal (Cardiac) exams.

# 5. Summary of Modifications and Newly Added Features

This submission device is a modification to DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System previously cleared in K123185.

The following is a brief overview of the modifications and newly added features. Detailed information is found in 003_Device Description of this submission, while section 005 Comparison to Legally Marketed Device includes a discussion of substantial equivalence with the predicate device(s).

- Newly added transducers ■
P7-3E P10-4E P7-3TE CW2s CW5s P4-2NE CB10-4E

### ■ Newly added needle-guided brackets NGB-020

NGB-021

#### ■ Newly added software options

LVO (Left Ventricular Opacification)

Smart Volume Smart NT

Stress Echo

Tissue Tracking QA

UltraView

- Other software modifications ■ Strain
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Strain Rate Color STIC HR Flow Color Smart 3D Echo Boost ■ Newly added calculation formulas Velocity Ratio RAR SMA/Ao CA/Ao Trace Spline Qp/Qs Qp-Qs VTI Ratio

All of the above modifications and newly added features have been compared with the predicate devices. The results show that these modifications and newly added features are substantially equivalent to the predicate devices.

### 6. 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)<br>Number |
|---------------------|--------------|------------------------------------|------------------|
| 1 | Mindray | DC-8<br>(Main predicate<br>device) | K123185 |
| 2 | Mindray | M7 | K121010 |
| 3 | Mindray | DC-T6 | K120699 |
| 4 | GE | Vivid E9 | K120201 |
| 5 | SIEMENS | ACUSON S2000 | K112596 |
| 6 | GE | Voluson E8 | K101236 |

DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System employs the same technology as the predicate devices. All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. All systems allow for specialized measurements of structures and flow, and calculations. The subject device also has the same intended uses and basic operating modes as the predicate devices.

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### 7. 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.

Non-clinical tests relied on in this premarket notification submission for a determination of substantial equivalence include testing showing compliance with the following standards:

- AAMI/ANSI ES60601-1: Medical electrical equipment Part 1: General 1 requirements for basic safety and essential performance
- IEC 60601-1-2: Medical electrical equipment Part 1-2: General requirements for ■ basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (Edition 3)
- IEC 60601-2-37: Medical electrical equipment Part 2-37: Particular requirements ● for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
- IEC 62304: Medical device software Software life cycle processes .
- IEC 62366: Medical devices Application of usability engineering to medical 행 devices
- ISO14971: Medical devices Application of risk management to medical devices .
- UD 2: Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment 1 Revision 3
- UD 3: Standard for Real Time Display of Thermal and Mechanical Acoustic Output ■ Indices on Diagnostic Ultrasound Equipment
- ISO 10993-1: Biological evaluation of medical devices -- Part 1: Evaluation and . testing within a risk management process

### 8. Clinical Tests:

Not Applicable.

### 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/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus.

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

August 15, 2013

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. % MARK JOB RESPONSIBLE THIRD PARTY OFFICIAL REGULATORY TECHNOLOGY SERVICES, LLC 1394 25TH STREET NW BUFFALO MN 55313

Re: K132341

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: IYN, IYO, and ITX Dated: July 25, 2013 Received: July 26, 2013

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA), 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 | P10-4E |
| C7-3E | V11-3E | P7-3TE |
| L12-3E | C11-3E | CW2s |
| L14-6NE | DE10-3E | CW5s |
| L14-6WE | V11-3E | P7-3E |
| P4-2E | V11-3WE | P4-2NE |
| D6-2E | L7-3E | CB10-4E |

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Smh

for

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

Enclosure

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# Indications for Use

510(k) Number (if known): 432341 K132341

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-skeletal (conventional, superficial), cardiac adult, cardiac pediatric, peripheral vessel, urology and transesophageal (Cardiac) exams.

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

Over-The-Counter Usc (21 CFR 801 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)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k)

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008-1

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| 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, 2,3, 4,6,7 | |
| | Abdominal | P | P | P | P | P | P | P | Note 1, 2,3, 4,5,6 | |
| | 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, 2,3, 4,6,7 | |
| | Trans-vaginal | P | P | P | | P | P | P | Note 1, 2,3, 4,6,7 | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal (Conventional) | P | P | P | N | 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, 2,4,5,6,7,9 | |
| | Cardiac Pediatric | P | P | P | P | P | P | P | Note 1, 2,4,5,6,7 | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | N | N | N | N | N | N | N | Note 1, 4,5,6 | |
| | Intra-cardiac | | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | P | P | P | N | 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、PW +Color+B、PW +Color+B、Power + PW+B. | | | | | | | | | |
| | * Intraoperative includes abdominal, thoracic, and vascular. | | | | | | | | | |
| | ** Small organ-breast, thyroid, testes. | | | | | | | | | |
| | *** Other use includes Urology. | | | | | | | | | |
| | Note 1: Tissue Harmonic Imaging. | | | | | | | | | |
| | Note 2: Smart3D | | | | | | | | | |
| | Note 3: 4D(Real-time 3D) | | | | | | | | | |
| | Note 4: iScape | | | | | | | | | |
| | Note 5: TDI | | | | | | | | | |
| | Note 6: Color M | | | | | | | | | |
| | Note 7: Biopsy Guidance | | | | | | | | | |
| | Note 8: Elastography | | | | | | | | | |
| | Note 9: Contrast imaging(contrast agent for LVO) | | | | | | | | | |
| | | | | | | | | | | |
| 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 &<br>Other | Neonatal Cephalic | | | | | | | | | |
| | 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<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. | | | | | | | | | |
| | | | | | | | | | | |
| | Note 2: Smart3D<br>Note 3: 4D(Real-time 3D) | | | | | | | | | |
| | Note 4: iScape | | | | | | | | | |
| | Note 5: TDI | | | | | | | | | |
| Note 6: Color M | | | | | | | | | | |
| | Note 7: Biopsy Guidance | | | | | | | | | |
| Note 8: Elastography | | | | | | | | | | |
| | Note 9 :Contrast imaging(contrast agent for LVO) | | | | | | | | | |
| | (PLEASE DO NOT WRITE RELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEFORD) | | | | | | | | | |

### Diagnostic Ultrasound Indications For Use Format

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

Transducer: N/A

System:

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Transducer: CS-2E

Intended Use:

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

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Transducer: C7-3E

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

| 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. | | | | | | | | |
| | Note 2: Smart3D | | | | | | | | |
| | Note 3: 4D(Real-time 3D) | | | | | | | | |
| Note 4: iScape | | | | | | | | | |
| Note 5: TDI | | | | | | | | | |
| | Note 6: Color M | | | | | | | | |

Note 7: Biopsy Guidance

Note 8: Elastography

Note 9: Contrast imaging(contrast agent for LVO)

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

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Transducer: L12-3E

| | | | | 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) | | | | | | | | |
| | 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 & | Neonatal Cephalic | P | P | P | | P | P | P | Note 1, 2, 4,6,7 |
| 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) | 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 | 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.<br>Note 1: Tissue Harmonic Imaging. | | | | | | | | | |
| Note 2: Smart3D | | | | | | | | | |
| Note 3: 4D(Real-time 3D) | | | | | | | | | |
| | Note 4: iScape | | | | | | | | |
| | Note 5: TDI | | | | | | | | |
| | Note 6: Color M | | | | | | | | |
| | Note 7: Biopsy Guidance | | | | | | | | |

Note 8: Elastography

Note 9: Contrast imaging(contrast agent for LVO)

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| System: | DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System | | | | | | | | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|-------------------|--------|--------------------------|------------------|----------------------|-----------------------|------------------------------------|--|
| 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<br>1 Only) | Specific (Track 1 & 3) | Amplitude<br>Combined<br>Color<br>PWD<br>B<br>CWD<br>M<br>Other (specify)<br>Doppler<br>(specify)<br>Doppler | | | | | | | | |
| 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 & | Neonatal Cephalic | P | P | P | | P | P | P | Note 1,2, 4,6,7 | |
| Other | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urcthral | | | | | | | | | |
| | | | | | | | | | | |
| | Trans-esoph. (non-Card.)<br>Musculo-skeletal (Conventional) | P | | | | | | | | |
| | Musculo-skeletal (Superficial) | P | P<br>P | P<br>P | | P<br>P | P<br>P | P<br>P | Note 1,2, 4,6,7<br>Note 1,2, 4,6,7 | |
| | Intravascular | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| | Peripheral vessel | P | P | | | | | | | |
| Peripheral<br>vessel | | | | 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. | | | | | | | | | |
| | ** Small organ-breast, thyroid, testes. | | | | | | | | | |
| | *** Other use includes Urology. | | | | | | | | | |
| | Note 1: Tissue Harmonic Imaging. | | | | | | | | | |
| | Note 2: Smart3D | | | | | | | | | |
| | Note 3: 4D(Real-time 3D) | | | | | | | | | |
| | Note 4: iScape | | | | | | | | | |
| | Note 5: TDI | | | | | | | | | |
| | Note 6:…