DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM 2-5MHZ CURVED LINEAR ARRAY, 5-10MHZ LINEAR ARRAY, 2-4MHZ PHASE ARRAY, 4-8MHZ TRANSV

K090229 · Chang Gung Medical Supplies & Equipment Corp. · IYN · Mar 13, 2009 · Radiology

Device Facts

• Record ID: K090229
• Device Name: DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM 2-5MHZ CURVED LINEAR ARRAY, 5-10MHZ LINEAR ARRAY, 2-4MHZ PHASE ARRAY, 4-8MHZ TRANSV
• Applicant: Chang Gung Medical Supplies & Equipment Corp.
• Product Code: IYN · Radiology
• Decision Date: Mar 13, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2

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); OB/Gyn and Urology.

Device Story

Compact, portable diagnostic ultrasound system; utilizes various transducers (curved linear, linear, phased array, transvaginal) to acquire ultrasonic signals; digital architecture performs beam forming, demodulation, and scan conversion; supports 2D B-mode, M-mode, Harmonic, Color/Power Doppler, and Pulse Wave/CW Doppler. Operated by physicians in clinical settings; provides real-time imaging on 15-inch LCD. Features include remote LAN image management and USB image transport. Clinicians use visual output and automated measurements (distance, area, velocity, PI, RI) to evaluate anatomy and hemodynamics; aids in diagnostic decision-making for abdominal, cardiac, vascular, and OB/GYN conditions.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified through acoustic output measurements (MI, TIS, TIC, TIB), imaging performance, and software validation consistent with FDA guidance for diagnostic ultrasound systems.

Technological Characteristics

64-channel all-digital beam former; progressive dynamic receive focusing; wide-band digital demodulation; native frequency digital scan converter. Modes: 2D, M-mode, Harmonic, Color/Power Doppler, PW/CW Doppler. Connectivity: LAN port, USB 2.0. Display: 15-inch LCD. Transducers: PA25 (2-4MHz), LA75 (5-10MHz), CLA35 (4-8MHz), TV65 (4-8MHz).

Indications for Use

Indicated for qualified physicians to perform diagnostic ultrasound imaging and fluid flow analysis in abdomen, cardiac (adult), small organs (breast, thyroid, testes), peripheral vascular, musculoskeletal (conventional), OB/GYN, and urology applications.

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

• SonoScape Ultrasound System SSI-1000 (K042369)

Submission Summary (Full Text)

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K090229

CGMC OPUS 5000 Diagnostic Doppler Ultrasound System

Chang Gung Medical Supplies & Equipment Corp.

## PREMARKET NOTIFICATION [510(k)] Summary

| Company Name: | Chang Gung Medical Supplies & Equipment Corp.<br>5F., No. 201-36, Dunhua N.Rd. Songshan District<br>Taipei, TAIWAN 10508 | MAR 1 3 2009 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| U.S. Agent: | Bob Leiker<br>Leiker Regulatory & Quality Consulting<br>7263 Cronin Circle Dublin, CA 94568<br>Telephone: [phone] | |
| Device Name: | CGMC Diagnostic Doppler Ultrasound System OPUS 5000 with<br>CGMC CLA35 Curved Linear Array 4-8MHz,<br>CGMC LA75 Linear Array 5-10MHz,<br>CGMC PA25 Phase Array 2-4MHz, and<br>CGMC TV65 Transvaginal Micro-Curved Linear Array 4-8MHz. | |
| Classification Name: | Regulatory Class: II<br>Review Category: Tier II<br>Classification Panel: Radiology<br>Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO<br>Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN<br>Diagnostic Ultrasound Transducer 21 CFR 892.1570, Product Code 90-ITX | |

### Predicate Device:

The SonoScape Ultrasound System SSI-1000 ( K042369 ) 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 CGMC OPUS 5000 diagnostic doppler ultrasound system is a compact and portable diagnostic 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 CGMC OPUS 5000:

- 64 Channel all digital beam former .
- Progressive dynamic receive focusing .
- Wide band all digital demodulation .
- Native frequency digital scan converter
- . . OPUS 5000 can be 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.

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

#### Intended Use:

The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen;Pediatric;Small Organ(breast,tests,thyroid);heart soft tissue; Peripheral Vascular; Musculo-skeletal(conventional) ; Ob/Gyn and Urology.

#### 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. Cardiac and Vascular package. |
| Operating Controls | TGC 8 slider, +/- 24dB 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 5 curves over 50-90 dB Gray Scale Control: 8 Settings Focal Number: 16 focal zone setting B persistence: 30-90% recursive Image Processing: Smoothing, edge enhancement PW sweeping speed 2,4,8 sec over display. PW Wall filter setting: 16 settings, 0.25 to 20% of PRF PW sample volume: 0.5 to 10mm 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 over 15-48 dB Spectrum baseline shift and invert Color ROI setting: trackball and set key to control size and Color steering on flat probe: +, 0, - Color Wall Filter: Color wall filter with 16 selection, 0.25-20% Color & B priority: C-B priority soft menu Color Packet size: preset per Exam range from 8 to 12 Color spatial filter: preset per Exam, horizontal, vertical, off Zoom factor: 1 to 10 continuously Freeze control: Toggling freeze key Cine control: step, play backward, play continuously |
| Acoustic Output | Track 3; MI, TIS, TIC, TIB<br>Derated Ispta: 720mW/cm2 maximum, TIS/ITIB/TIC: 0.1-4.0 Range,<br>Mechanical Index: 1.9 Maximum, or Derated Isppa: 190 W/cm 2max |

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all capital letters and is evenly spaced around the circle.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Chang Gung Medical Supplies & Equipment Corp. % Mr. Bob Leiker

Owner & Manager

Leiker Regulatory & Quality Consulting

7263 Cronin Circle

DUBLIN CA 94568

Re: K090229

Trade/Device Name: CGMC OPUS 5000 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: January 28, 2009 Received: January 30, 2009

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 CGMC OPUS 5000 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

PA25 2.5 MHz Phased Array LA75 7.5 MHz Linear Array CLA35 3.5 MHz Curved Linear Array TV65 6.5 MHz Trans-Vaginal/Trans-Rectal Micro-Curved Linear Array

MAR Į 3 2009

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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 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); 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 contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Lauren Hefner at [phone].

Sincerely yours,

C. Hecks Leum

ne M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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## Indications For Use

510(k) Number (if known):__K090229

Device Name: CGMC OPUS 5000 Diagnostic 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); OB/Gyn and Urology.

| Prescription Use | ✓ |
|-----------------------------|---|
| (Part 21 CFR 801 Subpart D) | |

AND/OR

| Over-The-Counter Use | __________ |
|------------------------|------------|
| (21 CFR 801 Subpart C) | |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | (Division Sign-Off) |
|---------------------|-----------------------------------------|
| | Division of Reproductive, Abdominal and |
| | Radiological Devices |
| Indications For Use | 510(k) Number K090229 |

| Section 1.3 | Page 1 of 6 |
|-------------|-------------|
|-------------|-------------|

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CGMC OPUS 5000 Diagnostic Ultrasound System

# Diagnostic Ultrasound Indications For Use Format

System:

CGMC OPUS 5000 ാന്തം വി ലോ 3000
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 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 | N | N | N | N | N | N | Note 1 | N |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | N | N | N | Note 1 | N |
| | Small Organ (breast, thyroid,<br>testes) | N | N | N | N | N | N | Note 1 | N |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | N | N | N | N | N | N | Note 1 | N |
| | Trans-vaginal | N | N | N | N | N | N | Note 1 | N |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal (Conventional) | N | N | N | N | N | N | Note 1 | N |
| | Musculo-skeletal (Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | N | N | N | N | N | N | Note 1 | N |
| Cardiac | Cardiac Adult | N | N | N | N | N | N | Note 1 | N |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | N | 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

Additional Comments:

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices age 2 of 6 510(k) Number _

Prescription Use (Per 21 CFR 801.109) Section 1.3

Indications For Use

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

## CGMC OPUS 5000 Diagnostic Ultrasound System Diagnostic Ultrasound Indications For Use Format

CGMC OPUS 5000 System: PA25 2.5 MHz Phased Array 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 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 | N | N | N | N | N | N | Note 1 | N |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (breast, thyroid,<br>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) | | | | | | | | |
| Cardiac | Cardiac Adult | N | N | N | N | N | N | Note 1 | N |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral 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/Color Doppler; B/Color Doppler/PWD and B/Power Doppler/PWD

Additional Comments:

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number

Page 3 of 6
K090229

Prescription Use (Per 21 CFR 801.109)
Section 1.3
Indications For Use

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

### CGMC OPUS 5000 Diagnostic Uftrasound System Diagnostic Ultrasound Indications For Use Format

CGMC OPUS 5000 System: LA75 7.5 MHz Linear Array 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 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 Organ (breast, thyroid,<br>testes) | N | N | N | N | N | N | Note 1 | N |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | N | N | Note 1 | N |
| | Musculo-skeletal (Conventional) | N | N | N | N | N | N | Note 1 | N |
| | Musculo-skeletal (Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | N | N | N | N | N | N | Note 1 | N |
| | Other (Specify) | | | | | | | | |

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

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

#### Additional Comments:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Section 1.3

Indications For Use

(Division Sign-Off)

Division of Reproductive, Abdominal and

Radiological Devices
Page 4 of 6
510(k) Number
K090229

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

### CGMC OPUS 5000 Diagnostic Ultrasound System Diagnostic Ultrasound Indications For Use Format

CGMC OPUS 5000 System: CLA35 3.5 MHz Curved Linear Array 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 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 | | | | | | | | |
| Other | Abdominal | N | N | N | | N | N | Note 1 | N |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (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) | N | N | N | | N | N | Note 1 | N |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | | | | | | | | |
| | Other (Specify) | | | | | | | | |

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

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

Additional Comments:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)
Section 1.3
Indications For Use

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number
Page 5 of 6
K090229

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

## Diagnostic Ultrasound Indications For Use Format

CGMC OPUS 5000 System: TV65 6.5 MHz Trans-Vaginal/Trans-Rectal Micro-Curved Linear Array 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 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 | | | | | | | | |
| Other | Abdominal | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (breast, thyroid,<br>testes) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | N | N | N | N | N | N | Note 1 | N |
| | Trans-vaginal | N | 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 | N | Note 1 | N |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | | | | | | | | |
| | Other (Specify) | | | | | | | | |

P = previously cleared by FDA; N = new indication;

E = added under this appendix

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

Additional Comments:

Concurrence of CDRH, Office of Device Evaluation (ODE

ce Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices Page 6 of 6 510(k) Number

Section 1.3

Indications For Use