DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM CURVED LINEAR ARRAY 2-5 MHZ TRANSDUCER LINEAR ARRAY 5-11 MHZ TRANSDUCER PHASE ARRA

K121983 · Benq Medical Technology Corpation · IYN · Sep 7, 2012 · Radiology

Device Facts

• Record ID: K121983
• Device Name: DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM CURVED LINEAR ARRAY 2-5 MHZ TRANSDUCER LINEAR ARRAY 5-11 MHZ TRANSDUCER PHASE ARRA
• Applicant: Benq Medical Technology Corpation
• Product Code: IYN · Radiology
• Decision Date: Sep 7, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ (breast, testes, thyroid), heart soft tissue, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, Cephalic, Ob/Gyn.

Device Story

Portable diagnostic Doppler ultrasound system; utilizes transducers (C52 curved linear, L115 linear, P42 phased array) to emit high-voltage pulses into tissue; detects reflected echoes to construct 2D B-mode, M-mode, color Doppler, power Doppler, and pulse wave Doppler images. Features 128-channel digital beam former, progressive dynamic receive focusing, and native resolution digital scan converter. Operated by physicians in clinical settings; includes 15-inch LCD display and control keyboard. System supports image management via LAN and USB. Provides real-time visualization and measurements (distance, area, velocity, PI, RI) to assist clinical diagnosis and patient management.

Clinical Evidence

Bench testing only. Device performance validated against safety and measurement standards including IEC 60601-1, AIUM/NEMA UD2, AIUM/NEMA UD3, and ISO 10993 for biocompatibility. No clinical data presented.

Technological Characteristics

Portable ultrasound system; 128-channel digital beam former; 15-inch LCD display. Transducers: C52 (2-5MHz), L115 (5-11MHz), P42 (2-4MHz). Modes: 2D, M-mode, Color/Power/Pulse Wave Doppler. Connectivity: LAN, USB 2.0. Standards: IEC 60601-1, EN 60601-1-2, EN 60601-2-37, ISO 10993. Acoustic output meets AIUM/NEMA UD2/UD3.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis in patients requiring evaluation of abdomen, cardiac, small organs (breast, testes, thyroid), heart soft tissue, peripheral vascular, musculoskeletal (conventional/superficial), pediatric, fetal, cephalic, and Ob/Gyn structures.

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

• GE Voluson i (K053435)

Submission Summary (Full Text)

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K121983

BenQ Medical Technology UP600 Diagnostic Doppler Ultrasound System 510(k) Submission

### PREMARKET NOTIFICATION [510(k)] Summary

SEP 7 2012

Company Name: BenQ Medical Technology Corporation 7F., No. 46, Zhou-Z St., Nei-Hu, Taipei 114, Taiwan

Contact:

Bob Leiker Leiker Regulatory & Quality Consulting 7263 Cronin Circle Dublin, CA 94568 Telephone: [phone] Fax: [phone] E-mail: [e-mail]

Device Name:

UP600 Diagnostic Doppler Ultrasound System with C52 Curved Linear Array 2-5MHz. L115 Linear Array 5-11MHz, P42 Phase Array 80 elements 2-4MHz. :

#### Common Name: Diagnostic Ultrasound Imaging System

Classification Name: Regulatory Class: II Review Category: Tier II Classification Panel: Radiology

> Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN Diagnostic Ultrasound Transducer 21 CFR 892.1570, Product Code 90-17X

#### Registration Number: 3003574554

Factory Location: Qisda Corporation 159 Shan-ying Road, Gueishan, Taoyuan 333, Taiwan

#### Reason for Submission:

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Device Act of 1990 revisions to 21 CFR, Part 807.92, Content and Format of a 510(k) Summary.

#### Predicate Device Comparison:

The GE Voluson i (K053435) is of a comparable and substantially equivalent type. It has the same technological characteristics, key safety and effectiveness features, physical design, and has the same intended uses and basic operating modes as the predicate device.

#### General Device Description:

The UP600 diagnostic doppler ultrasound system is a compact and portable diagnostic

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BenQ Medical Technology UP600 Diagnostic Doppler Uitrasound System 510(k) Submission ultrasound device, have integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The user interface includes a specialized control keyboard and color 15-inch LCD display. The all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features.

The major features of the UP600:

- · 128 Channel all digital beam former
- Progressive dynamic receive focusing
- · Wide band all digital demodulation
- Native resolution digital scan converter
- . Hand carried for portable use
- Remote access image management through LAN port .
- USB2.0 flash drive for image transport and software upgrade
- Supports 2D B-mode, M-mode, Harmonic Image, Color, Power Doppler, Pulse wave Doppler, and CW.

#### Intended Use:

The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ (breast, testes, thyroid), heart soft tissue, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, Cephalic. Ob/Gyn.

#### Technological Characteristics:

| Display Modes | Single and dual 2-D; Display of Duplex 2-D/M-mode; 2-D/Pulsed Doppler and<br>Triplex 2-D/CD/Pulsed Doppler image formats; Dual B and Color in real time |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Measurements | Distance; area; circumference; calipers; velocity, PI, RI. OB, Urology, Cardiac<br>and Vascular package. |
| Principle of<br>Operation | Applying high voltage burst to the Piezoelectric material in the transducer and<br>detect the reflected echo to construct the 2-D B-mode, Doppler color, and<br>Doppler spectrum image for diagnostic purpose. |

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| Operating<br>Controls | Low noise TGC: 8 slider settings Depth Range: 3 to 24 cm Image sector size: 32 lines to full B (256 lines) Image Sector position: Steering within full maximum B orientation flip: L/R key with marking on the screen B Dynamic range control: preset 14 curve settings Gray Scale Control: 7 Settings Focal Number: up to 12 focal zone settings B persistence: 30-90% 7 settings Image Processing: Smoothing, edge enhancement PW sweeping speed 2,4,6,8 sec over display. PW Wall filter setting: 16 settings, 0.25 to 20% of PRF PW sample volume: 1 to 20mm with 0.5mm step size. PW/B update: with UPDATE key PW cursor steering: Steer soft key PW angle correction: 0 to 70 degree user control PW trace: Peak, Mean PW spectrum dynamic range: 5 preset curve settings Spectrum baseline shift and invert Color ROI setting: trackball and set key to control size and position Color steering on flat probe: +, 0, - Color Wall Filter: Color wall filter with 16 selection, 0.25-20% Color Packet size: preset per Probe and Exam Zoom factor: 1 to 10 continuously Freeze control: Toggling freeze key Cine control: step, play backward, play continuously |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Acoustic<br>Output | Track 3; MI, TIS, TIC, TIB<br>Derated Ispta: 720mW/cm2 maximum, TIS/TIB/TIC: 0.1-4.0 Range,<br>Mechanical Index: 1.9 Maximum, or Derated Isppa: 190 W/cm 2max |

### SAFETY CONSIDERATIONS:

UP600 has been designed to meet the following voluntary and measurement standards:

- EC 60601-1 Safety of Medical Electric Equipment .
- AIUM/NEMA UD2 Acoustic Output Measurement Standard for Diagnostic Ultrasound . Equipment
- AIUM NEMA UD3 Standard for Real-time Display of Thermal and Mechanical Acoustic . Output Indices on Diagnostic Ultrasound Equipment
- Acoustic Output Measurement and Labeling Standard for Diagnostic Ultrasound Equipment . Revision 1 (AIUM 1998)

Safety and EMC Requirements for Medical Equipment

- EN 60601-1 ●
- EN 60601-1-2 ●
- EN 60601-2-37 ●
- ISO 10993 Biocompatibility �

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10903 New Hampshire Avenue Silver Spring, MD 20993

SEP 7 2012

BenQ Medical Technology Corporation % Mr. Bob Leiker Owner/Manager Leiker Regulatory & Quality Consulting 7263 Cronin Circle DUBLIN CA 94568

Re: K121983

Trade/Device Name: UP600 Diagnostic Doppler Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory: II Product Code: IYN, IYO, ITX Dated: August 4, 2012 Received: August 7, 2012

Dear Mr. Leiker:

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 UP600 Diagnostic Doppler Ultrasound System, as described in your premarket notification:

Transducer Model Number

C52 Curved Linear Array 2-5MHz L115 Linear Array 5-11MHz P42 Phase Array 80 elements 2-4MHz

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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 vou have any questions regarding the content of this letter, please contact Gary Levine at [phone].

Sincerely Yours,

Muhan D'O'hern for

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

Enclosure(s)

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BenQ Medical Technology UP600 Diagnostic Doppler Ultrasound System

510(k) Submission

# Tab 3 Indications For Use

510(k) Number (if known):

#### Device Name:

## UP600 Diagnostic Doppler Ultrasound System

Indications for Use: The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ (breast, testes, thyroid), heart soft tissue, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, Cephalic, Ob/Gyn.

Prescription Use X (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 Diagnostic Devices (OIVD)

(Division Sign-Off)
Division of Radiological Devices

# Indications For Use

210/

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### BenQ Medical Technology UP600 Diagnostic Doppler Ultrasound System Diagnostic Ultrasound Indications for Use Form

### System:

### UP600 Diagnostic Doppler Ultrasound System Diagnostic Ultrasound Pulsed Echo System Diagnostic Ultrasound Pulsed Doppler Imaging System

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

| Clinical Application | | Mode of Operation | | | | | | | |
|------------------------------|------------------------------------------|-------------------|---|-----|-----|------------------|---------------------------------|--------------------|-------------------------------|
| General<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Tissue<br>Harmonic<br>Imaging |
| Ophthalmic | Ophthalmic | N | N | N | | N | N | Note 1 | N |
| Fetal<br>Imaging &<br>Other | Fetal | N | N | N | | N | N | Note 1 | N |
| | Abdominal | N | N | N | | N | N | Note 1 | N |
| | Intra-operative Specify | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | | N | N | Note 1 | N |
| | Small Organ (breast,<br>thyroid, testes) | N | N | N | | N | N | Note 1 | N |
| | Neonatal Cephalic | N | N | N | N | N | N | Note 1 | N |
| | Adult Cephalic | N | N | N | N | N | N | Note 1 | N |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | | N | N | Note 1 | N |
| | Musculo-skeletal<br>(Superficial) | N | N | N | | N | N | Note 1 | N |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | N | N | N | | N | N | Note 1 | N |
| Cardiac | Cardiac Adult | N | N | N | N | N | N | Note 1 | N |
| | Cardiac Pediatric | N | N | N | N | N | N | Note 1 | N |
| | Intravascular(Cardiac) | | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | | N | N | Note 1 | N |
| | Other (specify) | | | | | | | | |

E = added under this appendix N = new indication; P = previously cleared by FDA Note 1: Combined includes: B/M; B/PWD; B/Color Doppler; B/Color Doppler; B/Color Doppler/PWD and B/Power Doppler/PWD

Prescription Use X (Part 21 CFR 801 Subpart D)

510

Indications For Use

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 Diagnostic Devices (OIVD)

Tab 3

Concurrence of CDRH, Office

**(Division Sign-Off)**
**Division of Radiological Devices**

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### Diagnostic Ultrasound Indications for Use Form

#### C52 Curved Linear Array 2-5MHz Transducer: Diagnostic Ultrasound Transducer

· · ·.

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

| Clinical Application | | Mode of Operation | | | | | | | |
|------------------------------|------------------------------------|-------------------|---|-----|-----|------------------|---------------------------------|--------------------|-------------------------------|
| General<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Tissue<br>Harmonic<br>Imaging |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal<br>Imaging &<br>Other | Fetal | N | N | N | | N | N | Note 1 | N |
| | Abdominal | N | N | N | | N | N | Note 1 | N |
| | Intra-operative Specify | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | N | N | N | | N | N | Note 1 | N |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | |
| | Other (specify) | | | | | | | | |

E = added under this appendix N = new indication; P = previously cleared by FDA; Note 1: Combined includes: B/M; B/PWD; B/Color Doppler; B/Power Doppler; B/Color Doppler/PWD and B/Power Doppler/PWD

Prescription Use X (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 Diagnostic Devices (OIVD)

(Division Sign-Off)
Division of Radiological Devices
510k K121983

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BenQ Medical Technology UP600 Diagnostic Doppler Ultrasound System

### Diagnostic Ultrasound Indications for Use Form

L115 Linear Array 5-11MHz Transducer: Diagnostic Ultrasound Transducer

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

| Clinical Application | | Mode of Operation | | | | | | | | |
|------------------------------|------------------------------------------|-------------------|---|-----|-----|------------------|---------------------------------|--------------------|-------------------------------|--|
| General<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Tissue<br>Harmonic<br>Imaging | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal<br>Imaging &<br>Other | Fetal | | | | | | | | | |
| | Abdominal | | | | | | | | | |
| | Intra-operative Specify | | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | | | | | | | | | |
| | Small Organ (breast,<br>thyroid, testes) | N | N | N | | N | N | Note 1 | N | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal. | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | | N | N | Note 1 | N | |
| | Musculo-skeletal<br>(Superficial) | N | N | N | | N | N | Note 1 | N | |
| | Intravascular | | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| | Other (specify) | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | | N | N | Note 1 | N | |
| | Other (specify) | | | | | | | | | |
| N = new indication. | | | | | | | | | | |

Note 1: Combined includes: B/M; B/PWD; B/Color Doppler; B/Power Doppler; B/Color Doppler/WD and B/Power Doppler/PWD

Prescription Use X · (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 Diagnostic Devices (OIVD) | | | |
| | | | |
| | | | |

(Division Sign-Off)
Division of Radiological Devices
510k K121983QIVD
Koivision of Radiolo

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### Diagnostic Ultrasound Indications for Use Form

P42 Phase Array 80 elements 2-4MHz Transducer: Diagnostic Ultrasound Transducer

.

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

| Clinical Application | | Mode of Operation | | | | | | | |
|------------------------------|------------------------------------------|-------------------|---|--------------------------------|-----|------------------|---------------------------------|-------------------------------|-------------------------------|
| General<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Tissue<br>Harmonic<br>Imaging |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal<br>Imaging & | Fetal | | | | | | | | |
| Other | Abdominal | N | N | N | N | N | N | Note 1 | N |
| | Intra-operative Specify | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (breast,<br>thyroid, testes) | | | | | | | | |
| | Neonatal Cephalic | N | N | N | N | N | N | Note 1 | N |
| | Adult Cephalic | N | N | N | N | N | N | Note 1 | N |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | |
| Cardiac | Cardiac Adult | N | N | N | N | N | N | Note 1 | N |
| | Cardiac Pediatric | N | N | N | N | N | N | Note 1 | N |
| | Intravascular(Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | | |
| Vessel | Other (specify) | | | | | | | | |
| N = new indication; | | | | P = previously cleared by FDA; | | | | E = added under this appendix | |

Note 1: Combined includes: B/M; B/PWD; B/Color Doppler; B/Power Doppler; B/Color Doppler/PWD and B/Power Doppler/PWD .

Prescription Use X (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 Diagnostic Devices (OIVD) |
|-------------------------------------------------------------------|
| (Division Sign-Off) |
| Division of Radiological Devices |

510k K121983