UP600 DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM

K132690 · Qisda Corporation · IYN · Feb 25, 2014 · Radiology

Device Facts

• Record ID: K132690
• Device Name: UP600 DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM
• Applicant: Qisda Corporation
• Product Code: IYN · Radiology
• Decision Date: Feb 25, 2014
• 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, and Ob/Gyn.

Device Story

UP600 is a compact, portable diagnostic ultrasound system. It uses piezoelectric transducers to transmit high-voltage bursts into the body and detect reflected echoes. The system features a 128-channel digital beamformer, progressive dynamic receive focusing, and a digital scan converter to process signals into 2D B-mode, M-mode, Color Doppler, Power Doppler, Pulse Wave Doppler, and CW Doppler images. Operated by physicians in hospitals or clinics, the device displays images on a 15-inch LCD. It supports specialized measurements (distance, area, circumference, velocity, PI, RI) and clinical packages for OB/GYN, cardiac, and vascular applications. Data is transported via USB. The system aids clinical decision-making by providing real-time visualization of anatomic structures and fluid flow, assisting in the diagnosis of various conditions across multiple clinical specialties.

Clinical Evidence

Bench testing only. The device was evaluated for safety and effectiveness through compliance with NEMA UD 2, NEMA UD 3, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, and ISO 10993-5 standards. No clinical data was required for this 510(k) submission.

Technological Characteristics

128-channel digital beamformer; progressive dynamic receive focusing; wide-band digital demodulation; native resolution digital scan converter. Transducers use piezoelectric materials; patient contact materials include RTV664 and Ultrason S2010 silicon rubber (ISO 10993-5 compliant). Connectivity via USB 2.0. Safety standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2, NEMA UD 3.

Indications for Use

Indicated for use by qualified physicians for diagnostic ultrasound imaging or fluid flow analysis of the human body, including Abdomen, Cardiac (adult/pediatric), Small Organ (breast, testes, thyroid), heart soft tissue, Peripheral Vascular, Musculo-skeletal (conventional/superficial), Pediatric, Fetal, Cephalic, Ob/Gyn, Trans-rectal, Trans-vaginal, and Urology.

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

• UP600 (K121983)
• Voluson i (K053435)
• OPUS 5000 (K102989)

Submission Summary (Full Text)

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# PREMARKET NOTIFICATION [510(k)] Summary

This Summary of Safety and Effectiveness is prepared in accordance with 21 CFR Part 807.92(c).

| 1. | Company Name: | BenQ Medical Technology Corporation<br>7F., No. 46, Zhou-Z St., Nei-Hu, Taipei 114, Taiwan | | | | FEB 25 2014 |
|----|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|-------------|
| | Factory Location: | Qisda Corporation<br>159 Shan-ying Road, Gueishan,<br>Taoyuan 333, Taiwan | | | | |
| | Contact: | Bob Leiker<br>Leiker Regulatory & Quality Consulting<br>7263 Cronin Circle<br>Dublin, CA 94568<br>Tel: [phone]    Fax: [phone] | | | | |
| 2. | Device Name: | UP600 Diagnostic Doppler Ultrasound System with<br>C52 Curved Linear Array 2-5MHz,<br>L115 Linear Array 5-11MHz,<br>P42 Phase Array 80 elements 2-4MHz,<br>E94 Micro Convex Array 4-9MHz | | | | |
| | | Common/Usual Name: Diagnostic Ultrasound System with Accessories | | | | |

Classification: Regulatory Class: II Review Category: Tier II

| Classification Name | 21 CFR Section | Product Code |
|------------------------------------------|----------------|--------------|
| Ultrasonic pulsed doppler imaging system | 892.1550 | 90-IYN |
| Ultrasonic pulsed echo imaging system | 892.1560 | 90-IYO |
| Diagnostic ultrasonic transducer | 892.1570 | 90-ITX |

# 2. Marketed Devices:

| Owner | Predicate Device | 510(k) Number |
|-------------------------|------------------|---------------|
| BenQ Medical Technology | UP600 | K121983 |
| GE Healthcare | Voluson i | K053435 |
| CGMC | OPUS 5000 | K102989 |

# 3. Device Description:

The UP600 diagnostic doppler ultrasound system is a compact and portable diagnostic ultrasound device, have integrated preprogrammed color ultrasound imaging system, capable of producing a resolution intended for clinical diagnostic imaging applications. The user interface includes a specialized control kevboard and color 15-inch LCD display. The digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the in depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows system integration to a variety of upgrade-able options and features.

Premarket Notification

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# 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 USB2.0 flash drive for image transport and software upgrade Supports 2D 8-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, thvroid), heart soft tissue, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, Cephalic, and Ob/Gyn.

## Technological Characteristics:

Display Modes:

Single and dual 2-D; Display of Duplex 2-D/M-mode; 2-D/Pulsed Doppler and Triplex 2-D/CD/Pulsed Doppler image formats; Dual B and Color in real time.

#### Measurements:

Distance: area; circumference; calipers; velocity, Pl, Rl. OB, Urology, Cardiac and Vascular package.

#### Principle of Operation

Applying high voltage burst to the Piezoelectric material in the transducer and detect the reflected echo to construct the 2-D B-mode, Doppler color, and Doppler spectrum image for diagnostic purposes.

The UP600 has been designed to meet the following product safety standards: NEMA UD 2, NEMA UD 3, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 10993-1.

#### 4. Indications for Use:

..

The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal/QB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Cardiac (adult & pediatric); Peripheral Vascular, Musculo-skeletal Conventional & Superficial, Transrectal and Transvaginal.

#### Comparison to Predicate Device:

The UP600 is of comparable type and substantially equivalent to both the GE Healthcare Voluson i, and the CGMC OPUS 5000. All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body, and have the same intended uses and basic operating modes as the predicate device. All systems allow for specialized measurements of structures and flow, and calculations.

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| BenQ Medical Technology UP600 Diagnostic Doppler Ultrasound System |
|--------------------------------------------------------------------|
|--------------------------------------------------------------------|

510(k) Submission

| | Submission Device | Predicate Device | Predicate Device |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | BenQ Medical Technology UP600 | CGMC OPUS 5000 | GE Voluson I |
| 510(k) Number | Pending | K102989 | K102989 |
| Indications for Use | This device is a general-purpose<br>ultrasonic imaging instrument intended<br>for use by a qualified physician for<br>evaluation of Abdomen; Pediatric; Small<br>Organ (breast, testes, thyroid); heart soft<br>tissue; Peripheral Vascular; Musculo-<br>skeletal; Ob/Gyn and Urology. | Intended for use of evaluating<br>Abdomen; Pediatric; Small Organ<br>(breast, testes, thyroid); heart soft<br>tissue; Peripheral Vascular, Musculo<br>-skeletal and Urology. | Intended for use of evaluating<br>Abdomen; Pediatric; Small Organ<br>(breast, testes, thyroid); heart soft<br>tissue; Peripheral Vascular,<br>Musculo -skeletal and Urology. |
| Design | Based on 128 channel full digital beam<br>former. | Based on 64 channel full digital<br>beam former. | Based on a 128 channel full digital<br>beam former. |
| Safety Compliance | IEC601-1 International Electrotechnical<br>Comission; Medical Electrical Equipment<br>IEC60601-2 International<br>Electrotechnical Comission;<br>Electromagnetic Compatibility | IEC601-1 International<br>Electrotechnical Comission; Medical<br>Electrical Equipment<br>IEC60601-2 International<br>Electrotechnical Comission;<br>Electromagnetic Compatibility | IEC 60601-1 Electrical medical<br>equipment,<br>IEC 60601-1-1 Electrical medical<br>equipment<br>IEC 60601-1-2 Electromagnetic<br>compatibility |
| Patient Contact<br>Materials | RTV664+Ultrason S2010 silicon rubber<br>complies with ISO10993-5 | RTV664+Ultrason S2010 silicon<br>rubber complies with ISO10993-5 | GE RTV630A/B silicon rubber<br>complies with ISO 10993-5 |
| Operation Mode | B (2-D), M, CFM,CPA, PW, CW, Tissue<br>Harmonic Image and combine mode | B, M, CFM, Power Doppler, PW,<br>CW, Tissue Harmonic Image and<br>combine mode | B-Mode (2D). M-Mode, M-Color-<br>Mode, Color Flow Mode, Power<br>Doppler Imaging, PW Doppler,<br>Volume Mode (3D/4D):, 3D Static.<br>3D with Color Flow, 4D Real-Time |
| Display Modes | Single and dual 2-D; Display of Duplex 2-<br>D/M-mode; 2-D/Pulsed Doppler and<br>Triplex 2-D/CD/Pulsed Doppler image<br>formats;<br>Dual B and Color in real time | Single and dual 2-D; Display of<br>Duplex 2-D/M-mode; 2-D/Pulsed<br>Doppler and Triplex 2-D/CD/Pulsed<br>Doppler image formats:<br>Dual B and Color in real time | Real-Time Triplex Mode, Multi-<br>image (split, quad). Colorized<br>Image. Time line display.<br>Independent Dual B/PW Display, |
| Display Monitor | 15" LCD color monitor | 15" LCD color monitor | High-Resolution 15-inch TFT LCD<br>Screen |
| Measurements | Distance; area; Volume; circumference:<br>Heart Rate: calipers; velocity; PI, RI,<br>Cardiac, OB/GYN and Vascular package. | Distance; area; Volume:<br>circumference; Heart Rate; calipers;<br>velocity; PI. RI, Cardiac, OB/GYN<br>and Vascular package. | Obstetrics, Gynecology,<br>Abdominal. Small-Parts, Vascular,<br>Pediatrics, Urology. Ortho,<br>Cardiology |
| Transducer Types &<br>Connectors | Convex and Micro-convex (endo-cavity),<br>Phase array, and Linear array probes.<br>Multi-port connector connects up to 2<br>transducers | Convex, Phase array, Linear array,<br>and Transvaginal Micro-Curved<br>Linear probes, Multi-port connector<br>connects up to 2 transducers. | Convex Array<br>· Linear Array<br>• Volume probes '4D' Convex<br>Array<br>· Volume probes '4D' Linear Array |
| Principle of Operation | Applying high voltage burst to the<br>Piezoelectric material in the transducer<br>and detect the reflected echo to construct<br>the 2-D B-mode, Doppler color, and<br>Doppler spectrum image for diagnostic<br>purpose. | Applying high voltage burst to the<br>Piezoelectric material in the<br>transducer and detect the reflected<br>echo to construct the 2-D B-mode,<br>Doppler color, Doppler spectrum<br>image for diagnostic purpose. | Applying high voltage burst to the<br>Piezoelectric material in the<br>transducer and detect the<br>reflected echo to construct the 2-D<br>B-mode, Doppler color, Doppler<br>spectrum image for diagnostic<br>purpose |
| Users / Sites | Hospitals, clinics usage | Hospitals, clinics usage | Hospitals, clinics usage |
| Acoustic Output | Track 3; MI, TIS, TIC, TIB<br>Derated Ispta: 720mW/cm2 maximum,<br>TIS/TIB/TIC:0.1-4.0 Range, Mechanical<br>Index: 1.9 Maximum, or Derated Isppa:<br>190 W/cm² max | Track 3; MI, TIS, TIC, TIB<br>Derated Ispta: 720mW/cm2<br>maximum, TIS/TIB/TIC: 0.1-4.0<br>Range, Mechanical Index: 1.9<br>Maximum, or Derated Isppa: 190<br>W/cm2 max | Track 3: MI, TIS, TIC, TIB<br>Derated Ispta: 720mW/cm2<br>maximum, TIS/TIB/TIC:0.1-4.0<br>Range, Mechanical Index: 1.9<br>Maximum, or Derated Isppa: 190<br>W/cm2 max |
| Labeling | Operator's Manual, brochure | Operator's Manual, brochure | Operator's Manual, brochure |
| Dimensions / Weight | Dimension:<br>Height 36.1cm<br>Width 36.3cm<br>Depth 18.7cm<br>Weight: 9kg | Dimensions<br>Height 40 cm<br>Width 40 cm<br>Depth 20 cm<br>Weight: 11kg | · Height: 59 mm (2.3 in)<br>• Width: 358 mm (14.2 in)<br>· Depth: 313 mm (12.4 in)<br>· Weight (no peripherals):<br>11 lb (5kg) |
| Power Requirements | Power requirements:<br>100 Volts AC, 2.5 Amps<br>120 Volts AC, 2.1 Amps<br>230 Volts AC, 1.1 Amps<br>250 Volts AC, 1 Amps<br>Power Consumption: 180 watts, max<br>Operating temperature 5-40° C; relative<br>humidity 10-80%; | Power requirements:<br>100 Volts AC, 3.3 Amps<br>120 Volts AC. 2.7 Amps<br>230 Volts AC, 1.4 Amps<br>250 Volts AC, 1.3 Amps<br>Power Consumption 200 watts, max<br>Operating temperature 15-40° C;<br>relative humidity 10-90%; | Electrical Power<br>· Voltage: 100 - 240 V<br>· Frequency: 50/60 Hz |

Premarket Notification

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K132690
Page 4 of 4
510(k) Submission

#### 5. Conclusion:

The UP600 is substantially equivalent in safety and effectiveness to the predicate systems. The systems are intended for diagnostic ultrasound imaging and fluid flow analysis. The systems have the same gray-scale. The systems have acoustic output levels below the applicable FDA limits. The systems are designed to applicable electrical and physical safety standards.

End of 510(k) Summary.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the seal is a stylized symbol resembling three overlapping waves or stripes, which is the department's emblem.

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

February 25, 2014

BenQ Medical Technology Corporation/Qisda Corporation % Mr. Bob Leiker Leiker Regulatory & Quality Consulting (LRQC) 7263 Cronin Circle DUBLIN CA 94568

Re: K132690

Trade/Device Name: UP600 Diagnostic Doppler Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: January 28, 2014 Received: January 30, 2014

Dear Mr. Leiker:

We have reviewed vour 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 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 Phased Array 80 elements 2-4MHz | E94 Micro Convex Array 4-9MHz |

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.

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Page 2-Mr. Leiker

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 (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.

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/Resources/orYou/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/ReportalProblem/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/ResourcesforYou/Industrv/default.htm.

Sincerely yours.

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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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved OMB No 0910-0120 |
|-----------------------------------------|----------------------------------|
| Food and Drug Administration | Expiration Date January 31, 2017 |
| Indications for Use | See PRA Statement on last page |

510(k) Number (if known)

್ನೂ

#### K132690

Device Name UP600 Diagnostic Doppler Ultrasound System

### Indications for Use (Describe)

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

Type of Use (Select one or both, as epplicable)

[X] Prescription Use (Part 21 CFR 801 Subpan D)

Over-The-Counter Use (21 CFR 801 Subpart Ci

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Rachological Health (CDRH) (Signature) Carpora

Smh. 7)

FORM FDA 3881 (1/14)

• **S.A.E. 10W-30** (1)

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- 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 | | | | | | | |
|---------------------------|---------------------------------------------|-------------------|---|-----|-----|------------------|---------------------------------|--------------------|-------------------------------|
| | | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Tissue<br>Harmonic<br>Imaging |
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | P | P | P | | P | P | Note 1 | P |
| | Abdominal | P | P | P | | P | P | Note 1 | P |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | P | Note 1 | P |
| | Small Organ(1) (Breast, Thyroid,<br>Testes) | P | P | P | | P | P | Note 1 | P |
| | Neonatal Cephalic | P | P | P | P | P | P | Note 1 | P |
| | Adult Cephalic | P | P | P | P | P | P | Note 1 | P |
| | Trans-rectal | N | N | N | | N | N | Note 1 | N |
| | Trans-vaginal | N | N | N | | N | N | Note 1 | N |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal (Conventional) | P | P | P | | P | P | Note 1 | P |
| | Musculo-skeletal (Superficial) | P | P | P | | P | P | Note 1 | P |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | P | P | P | | P | P | Note 1 | P |
| Cardiac | Cardiac Adult | P | P | P | P | P | P | Note 1 | P |
| | Cardiac Pediatric | P | P | P | P | P | P | Note 1 | P |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | | P | P | Note 1 | P |

N = new indication; P = previously cleared by FDAE = added under this appendix

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

Prescription Use_ ど (Pari 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 Device Evaluation (ODDF)

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System: UP600 Diagnostic Doppler Ultrasound System C52 Curved Linear Array 2-5MHz 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 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color Doppler | Power (Amplitude) Doppler | Other* Combined | Tissue Harmonic Imaging |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging & Other | Fetal | P | P | P | | P | P | Note 1 | P |
| | Abdominal | P | P | P | | P | P | Note 1 | P |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ ¹ (Breast, Thyroid, Testes) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal (Conventional) | | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | P | P | P | | P | P | Note 1 | P |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | | | | | | | | |
| | Other (Specify) | | | | | | | | |

N = new indication: P = previously cleared by FDA E = added under this appendix

N = new indication; P = previously cleared by FDA E = added under this appendix Note 1: Combined includes: BM: BIPWD; BIColor Doppler: BIPower Doppler/PWD and BiPower Doppler/PWD

Prescription Use N (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 Device Evaluation (0)DE)

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UP600 Diagnostic Doppler Ultrasound System System: L115 Linear Array 5-11MHz Diagnostic Ultrasound Transducer

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

Clinical Application Mode of Operation General Specific B M |PWD CWD Color Power Other* Tissue (Track 1 Only) (Tracks 1 & 3) Doppler Combined Harmonic (Amplitude) Doppler Imaging Ophthalmic Ophthalmic Fetal Imaging & |Fetal Other Abdominal Intra-operative (Specify) Intra-operative (Neuro) Laparoscopic Pediatric Small Organ (1) (Breast, Thyroid, P P P P P ာ Note 1 Testes) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Card.) Musculo-skeletal (Conventional) P P P P P Note 1 P P P P P Musculo-skeletal (Superficial) p Note 1 P Intravascular Other (Ob/GYN) Cardiac Cardiac Adult Cardiac Pediatric Intravascular (Cardiac) Trans-esoph. (Cardiac) . Intra-cardiac Other (Specify) P P Peripheral Peripheral vessel p P P p Note 1 Vessel Other (Specify)

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

Prescription Use 1 (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 Device Fivaliation (ODD)

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System: UP600 Diagnostic Doppler Ultrasound System P42 Phased Array 80 elements 2-4MHz 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 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 Imaging &<br>Other | Fetal | | | | | | | | |
| | Abdominal | P | P | P | P | P | Note 1 | P | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ¹¹ (Breast, Thyroid,<br>Testes) | | | | | | | | |
| | Neonatal Cephalic | P | P | P | P | P | Note 1 | P | |
| | Adult Cephalic | P | P | P | P | P | Note 1 | P | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal (Conventional) | | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | |
| Cardiac | Cardiac Adult | P | P | P | P | P | Note 1 | P | |
| | Cardiac Pediatric | P | P | P | P | P | Note 1 | P | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | |
| | Other (Specify) | | | | | | | | |

N = now indication; P = previously cleared by FDA E = added under this appondix Note 1: Combined includes: BM: BIPWD: BIColor Doppler: BIPower Doppler/PWD and BiPower Doppter/PWD

Prescription Use_ バ (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 Device Evaluation (DDDI)

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

#### UP600 Diagnostic Doppler Ultrasound System System: E94 Micro Convex Array 4-9MHz Diagnostic Ultrasound Transducer

ﺎ

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

| Clinical Application | | Mode of Operation | | | | | | | |
|---------------------------|-------------------------------------------|-------------------|---|-----|-----|------------------|---------------------------------|--------------------|-------------------------------|
| General<br>(Track 1 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 Imaging &<br>Other | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ1 (Breast, Thyroid,<br>Testes) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | N | N | N | | N | N | Note 1 | N |
| | Trans-vaginal | N | N | N | | N | N | Note 1 | N |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal (Conventional) | | | | | | | | |
| | Musculo-skeletal (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) | | | | | | | | |

Note 1: Combined includes: BM: BIPWD: BlColor Doppler: BlColor Doppler/PVD and BiPower Doppler/PWD

Prescription Use_ ﺮ ﺍﻟﻤﺮﺍ (Part 2) 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 Device Evaluation (ODE)