OPUS DIAGNOSTIC ULTRASOUND SYSTEM & TRANSDUCERS

K102989 · Chang Gung Medical Technology Co., Ltd. Linkou Fac · IYN · Dec 9, 2010 · Radiology

Device Facts

• Record ID: K102989
• Device Name: OPUS DIAGNOSTIC ULTRASOUND SYSTEM & TRANSDUCERS
• Applicant: Chang Gung Medical Technology Co., Ltd. Linkou Fac
• Product Code: IYN · Radiology
• Decision Date: Dec 9, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

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

Device Story

CGMC OPUS 5000 is a portable diagnostic Doppler ultrasound system. It utilizes piezoelectric transducers to emit high-voltage pulses and detect reflected echoes. The system features a 64-channel digital beamformer, progressive dynamic receive focusing, and wide-band digital demodulation. It supports 2D B-mode, M-mode, Harmonic Imaging, Color Doppler, Power Doppler, Pulse Wave (PW) Doppler, and CW. Operated by physicians in clinical settings, the device displays images on a 15-inch LCD. Users control imaging via a specialized keyboard, trackball, and soft-menu interface. The system provides measurements including distance, area, circumference, velocity, PI, and RI. Output data assists clinicians in diagnostic evaluation of various anatomical structures. Images can be managed via LAN or transported via USB 2.0. The device benefits patients by providing non-invasive, real-time diagnostic imaging.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing, including acoustic output measurements per AIUM/NEMA UD2/UD3 standards and compliance with electrical safety and EMC requirements (IEC 60601-1, EN 60601-1-2).

Technological Characteristics

Portable ultrasound system with 64-channel digital beamformer. Transducers: Phased Array, Curved Linear Array, Linear Array, Transvaginal, Micro-Convex. Piezoelectric sensing. Modes: 2D, M-mode, PW/CW Doppler, Color/Power Doppler, Tissue Harmonic Imaging. Connectivity: LAN, USB 2.0. Standards: IEC 60601-1, AIUM/NEMA UD2, AIUM/NEMA UD3, ISO 10993 (biocompatibility).

Indications for Use

Indicated for qualified physicians to perform diagnostic ultrasound imaging or fluid flow analysis of the human body, including abdomen, cardiac, small organs (breast, testes, thyroid), heart soft tissue, peripheral vascular, musculoskeletal (conventional), Ob/Gyn, 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

• SonoScape Ultrasound System SSI-1000 (K042369)

Submission Summary (Full Text)

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K102989

DEC - 9 2010

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

- Chang Gung Medical Technology Co., Ltd. Company Name: 5F , No. 201-32, Tung Hwa North Rd., Taipei (105), Taiwan, R.O.C.
- Contact: Bob Leiker Leiker Regulatory & Quality Consulting 7263 Cronin Circle Dublin, CA 94568 Telephone: [phone] Fax: [phone] E-mail: [e-mail]
- U.S. Agent: Bob Leiker Leiker Regulatory & Quality Consulting 7263 Cronin Circle Dublin, CA 94568 Telephone: [phone] Fax: [phone] E-mail: [e-mail]
- CGMC Diagnostic Doppler Ultrasound System OPUS 5000 with Device Name: CGMC CLA35 Curved Linear Array 4-8MHz. CGMC LA75 Linear Array 5-10MHz, CGMC PA25 Phase Array 2-4MHz, and CGMC TV65 Transvaginal Micro-Curved Linear Array 4-8MHz, CGMC MCLA65 Micro Curved Linear Array 5-8MHz, CGMC LA80N 192 Elements Linear Array 5-12MHz, CGMC LA85N 192 Elements Linear Array 5-12MHz.
- Common Name: Diagnostic Ultrasound 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-ITX

Registration Number: 3005706637

Factory Location: Chang Gung Medical Technology Co., Ltd. Linkou Factory 2F., No. 118, Nan Lin Rd., Taishan Shiang, Taipei (243), Taiwan, R.O.C.

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:

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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 costeffective 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.

### Intended Use:

The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen;Pediatric;Small Orqan(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<br>and<br>Triplex 2-D/CD/Pulsed Doppler image formats; Dual B and Color in real<br>time. |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Measurements | Distance; area; circumference; calipers; velocity, PI, RI. Cardiac and<br>Vascular package. |
| Principle of<br>Operation | Applying high voltage burst to the Piezoelectric material in the transducer<br>and detect the reflected echo to construct the 2-D B-mode, Doppler color,<br>and Doppler spectrum image for diagnostic purpose. |

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| Operating<br>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<br>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 |

# SAFETY CONSIDERATIONS:

OPUS 5000 has been designed to meet the following voluntary and measurement standards:

- IEC 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 60601-1-1
- . EN 60601-1-2
- . EN 60601-2-37
- . ISO 10993 Biocompatibility

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Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Chang Gung Medical Technology Co., Ltd. % Mr. Bob Leiker Manager Leiker Regulatory & Quality 7263 Cronin Circle DUBIN CA 94568

DEC - 9 2010

Re: K102989

Trade/Device Name: OPUS 5000 Diagnostic Doppler 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: September 29, 2010 Received: October 6, 2010

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

Transducer Model Number

PA25-2.5 MHz Phased Array CLA35-3.5 MHz Curved Linear Array LA75-7.5 MHz Linear Array TV65-6.5 MHz Transvaginal MCLA65-6.5 MHz Micro Convex Transducer LA80N-8.0 MHz 192 Element Linear Array LA85N-8.5 192 Element Linear Array

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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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

Sincerely yours,

Signature

David G. Brown, Ph.D. Acting 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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# Tab 3 Indications For Use

K102989
DEC - 9 2010

510(k) Number (if known):

OPUS 5000 Diagnostic Doppler Ultrasound System Device Name:

- The device is a general-purpose ultrasonic imaging instrument Indications for Use: intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ (breast, tests, thyroid), heart soft tissue, Peripheral Vascular, Musculo-skeletal (conventional), Ob/Gyn and Urology.
Prescription Use X (Part 21 CFR 801 Subpart D)

Indicatio

AND/OR . Over-The-Counter Use (21 CFR 807 Subpart C)

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| | Division of Radiological Devices |
| | Office of In Vitro Diagnostic Device Evaluation and Safety |
| 510K | K102989 |

ons For Use

Tab 3 , and

Page 1 of 9

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#### System: CGMC OPUS 5000 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 | | | | | | | | |
| Fetal<br>Imaging&<br>Other | Fetal | | | | | | | | |
| | 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 | | | | | | | | |
| | 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<br>(Conventional) | N | N | N | | N | N | Note 1 | N |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | N | N | N | | N | N | Note 1 | N |
| Cardiac | Cardiac Adult | N | N | N | | N | N | Note 1 | N |
| | 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) | | | | | | | | |

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)

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(Division Sign-Off n of Radiological Davin age 2 of 9

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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<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 (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) | | | | | | | | |
| Cardiac | Cardiac Adult | P | P | P | P | P | P | Note 1 | P |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | |
| | Other (specify) | | | | | | | | |

N = new indication;

P = previously cleared by FDA; K090229

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)

510K

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Division Sign-Off adinlaninel D and Safety Page 3 of 9

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Transducer: CLA35 - 3.5 MHz Curved Linear Array 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 | | | | | Color | Power | Other* | Tissue |
| (TRACK 1 | (TRACKS 1 & 3) | B | M | PWD | CWD | Doppler | (Amplitude) | Combined | Harmonic |
| ONLY) | | | | | | | Doppler | | Imaging |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal | Fetal | | | | | | | | |
| Imaging& | | | | | | | | | |
| Other | Abdominal | P | P | P | | P | P | Note 1 | P |
| | 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) | P | P | P | | P | P | Note 1 | P |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | | |
| Vessel | Other (specify) | | | | | | | | |

N = new indication;

P = previously cleared by FDA; K090229

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

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

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

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Tab 3

Indications For Use

:

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Transducer: LA75 - 7.5 MHz Linear Array 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) | P | P | P | | P | P | Note 1 | P | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | P | P | P | | P | P | Note 1 | P | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| | Other (specify) | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | | P | P | Note 1 | P | |
| | Other (specify) | | | | | | | | | |
| N = new indication; | | | | P = previously cleared by FDA; K090229 | | | | 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)

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Tab 3
Page 5 of 9
510K. K102989

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Transducer: TV65 - 6.5 MHz Transvaginal 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 (specify) | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | P | P | P | | P | P | Note 1 | P | |
| | Trans-vaginal | P | P | P | | P | P | Note 1 | P | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | | |
| | Musculo-skeletal<br>(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<br>Vessel | Peripheral vessel | | | | | | | | | |
| | Other (specify) | | | | | | | | | |

N = new indication;

P = previously cleared by FDA; K090229

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 ਮ (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)

510K

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
Tab 3

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MCLA65 - 6.5 MHz Micro Convex Transducer 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 | | | | | | | | | |
| | Small Organ (breast,<br>thyroid, testes) | N | N | N | | N | N | Note 1 | N | |
| | Small Organ (specify) | 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) | | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | | |
| Cardiac | Cardiac Adult | N | N | N | | N | N | Note 1 | N | |
| | Cardiac Pediatric | | | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| | Other (specify) | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | | |
| | Other (specify) | | | | | | | | | |

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)

Tab 3

510K

TC

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Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safeur

Indications For Use

Page 7 of 9

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LA80N - 8.0 MHz 192 Element 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 | | | | | | Tissue<br>Harmonic<br>Imaging |
|------------------------------|------------------------------------------|---|-------------------|-----|-----|------------------|---------------------------------|--------------------|-------------------------------|
| 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 | |
| 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) | | | | | | | | |
| | 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) | | | | | | | | |

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)

510K

Concurrence of CDRH, Office of In Vitro Diagnostie Devices (OIVD)

Signature

(Division Sigr Division of Radiolog Office of In d Safety Page 8 of 9 Tab 3

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Transducer: LA85N - 8.5MHz 192 Element Linear Array Diagnostic Ultrasound Transducer

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

| Clinical Application | | Mode of Operation | | | | | | Tissue<br>Harmonic<br>Imaging | |
|------------------------------|----------------------------------------------------------------------|-------------------|---|-----|-----|------------------|---------------------------------|-------------------------------|--------------------|
| 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 |
| 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) | | | | | | | | |
| | 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: | P = previously cleared by FDA; K090229 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)

SIOK

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Signature

Division Sion-Off Division of Radiological Do Page 9 of 9

# Indications For Use