ULTRASOUND WORKSTATION, UIWS-300A

K982976 · Toshiba America Medical Systems, In.C · LLZ · Nov 24, 1998 · Radiology

Device Facts

• Record ID: K982976
• Device Name: ULTRASOUND WORKSTATION, UIWS-300A
• Applicant: Toshiba America Medical Systems, In.C
• Product Code: LLZ · Radiology
• Decision Date: Nov 24, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

This device is to serve as a workstation for the capture, storage, review and analysis of ultrasound images, both still and dynamic. This devices is designed to support functional diagnósis by performing display, processing, measurement and analysis of ultrasound images.

Device Story

UIWS-300A is a digital workstation connecting to Toshiba PowerVision ultrasound scanners; captures, stores, reviews, and analyzes still and dynamic ultrasound images. Hardware includes standard desktop PC, keyboard, mouse, and monitor. Clinicians use the system to perform image display, processing, and measurements to support functional diagnosis. Output is viewed on the workstation monitor to assist in clinical decision-making and patient diagnosis.

Clinical Evidence

Bench testing only.

Technological Characteristics

Standard desktop PC architecture; DICOM SCU storage; MJPEG compression (AVI format) or non-compressed (IMG format); monitor testing per JIS C6101; safety per IEC 60601-1-1 (1992).

Indications for Use

Indicated for the retrieval, storage, and analysis of passive and active ultrasound images for diagnostic support.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• Nova MicroSonics, Image View DCR

Submission Summary (Full Text)

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510(k) Summary

K98 2976

| Date: | 25 August 1998 |
|---------------------------------------|--------------------------------------------------------------|
| Submitter's Name: | Toshiba America Medical Systems, Inc. |
| Submitter's Address: | P.O. Box 2068, 2441 Michelle Drive,<br>Tustin, CA 92781-2068 |
| Submitter's Contact: | Paul Biggins, Regulatory Affairs Specialist, [phone] |
| Establishment Registration<br>Number: | 2020563 |
| Device Proprietary Name: | Ultrasound Workstation, UIWS-300A |
| Common Name: | Picture Archiving and Communications System |
| Regulatory Class: | Class II per 21 CFR § 892.2050; 90LLZ |
| Predicate Device: | Nova MicroSonics, Image View DCR |
| Reason For Submission | New Product |

## Description of this Device:

The UIWS-300A, Ultrasound Workstation, is an all digital workstation that can be connected to Toshiba PowerVision diagnostic ultrasound scanners. Its function is to provide the user with the ability to view images, annotate image data and perform analysis on image data. The unit is comprised of a standard desktop type personal computer, keyboard, mouse, monitor and connecting cables.

## Summary of Intended Uses:

This device is to serve as a workstation for the capture, storage, review and analysis of ultrasound images, both still and dynamic. This devices is designed to support functional diagnósis by performing display, processing, measurement and analysis of ultrasound images.

## Comparison to Predicate Device

The user features of the UIWS-300A Ultrasound Workstation and the Nova MicroSonics Image Vue DCR (K) are very similar.

## Conformance to Standards

The following standards apply to the design and manufacture of the UIWS-300A Ultrasound Workstation:

| Image Storage: | DICOM SCU Storage |
|---------------------------|-------------------------------------------------------|
| Monitor Testing: | JIS C6101 |
| Safety: | IEC 60601-1-1 (AMD1) [1992] |
| Image Compression: MJPEG: | Compressed -AVI format<br>Non-compressed - IMG format |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 24 1998

Paul Biggins Regulatory Affairs Specialist Toshiba America Medical Systems, Inc. 2441 Michelle Drive PO Box 2068 Tustin, CA 92781-2068

K982976

Re:

Ultrasound Workstation, UIWS-300A Dated: August 25, 1998 Received: August 26, 1998 Regulatory class: II 21 CFR 892,2050/Procode: 90 LLZ

Dear Mr. Biggins:

We have reviewed your Section 510(k) 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 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) 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 the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in yitn diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrt/dsmaldsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.

Director, Division of Reproductiv Abdominal, Ear, Nose and Thro and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page ____ of _________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

Retrieval and storage of both passive and active ultrasound images Analysis of ultrasound images

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

Concurrence/off CDRH, Office of Device Evaluation (ODE)

Vorid a. Seym

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

**Prescription Use**
(Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________

(Optional Format 1-2-96)