GE ADVANTAGE DIGITIZER WORKSTATION

K970628 · Ge Medical Systems, Inc. · LMD · May 12, 1997 · Radiology

Device Facts

• Record ID: K970628
• Device Name: GE ADVANTAGE DIGITIZER WORKSTATION
• Applicant: Ge Medical Systems, Inc.
• Product Code: LMD · Radiology
• Decision Date: May 12, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2020
• Device Class: Class 1

Intended Use

The GE Advantage Digitizer Workstation is a film digitizing and DICOM converting quality assurance (QA) workstation that permits viewing and annotation changes of digitized images prior to lossless storage to a hard drive or transmission to another DICOM device on a local or wide area network.

Device Story

Device consists of PC Pentium computer, Windows NT OS, keyboard, mouse, SVGA monitor, application software, and film digitizer. Operates as QA workstation; digitizes medical film; converts images to DICOM format. Allows clinician viewing and annotation of digitized images. Supports lossless storage to hard drive and transmission via local or wide area network. Used in clinical environments for image management and QA workflows. Output facilitates clinical review and archival of medical imaging data.

Clinical Evidence

Bench testing only; system design verification tests performed to ensure conformance with specifications; additional validation conducted for user satisfaction.

Technological Characteristics

PC Pentium-based architecture; Windows NT operating system; SVGA color monitor; film digitizer hardware; DICOM connectivity; software-based image processing and annotation.

Indications for Use

Indicated for use by clinicians as a quality assurance workstation for digitizing medical film, viewing, annotating, and converting images to DICOM format for storage or network transmission.

Regulatory Classification

Identification

A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.

Predicate Devices

• Dejarnette Imageshare Film Digitizer Acquisition Gateway
• Lumisys DICOM Toolkit
• RadWorks Medical Imaging Software

Submission Summary (Full Text)

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MAY 12 1997
GE Medical Systems
General Electric Company
P.O. Box 414, Milwaukee, WI 53201
K970628

# 510(k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).

**Identification of Submitter:**
GE Medical Systems
PO Box 414
Milwaukee, WI 53201

**Contact:**
Larry Kroger, Ph.D.
Manager, Regulatory Programs
414-544-3894

**Date Prepared:** February 17, 1997

**Product Identification:** GE Advantage Digitizer Workstation. This is a new product release.

**Device Description:** The GE Advantage Digitizer Workstation consists of a PC Pentium computer running Windows NT with a keyboard, mouse and SVGA color monitor, application software and a film digitizer.

**Indications for Use:** The GE Advantage Digitizer Workstation is a film digitizing and DICOM converting quality assurance (QA) workstation that permits viewing and annotation changes of digitized images prior to lossless storage to a hard drive or transmission to another DICOM device on a local or wide area network.

**Comparison with Predicate Device:** The GE Advantage Digitizer Workstation is comparable in key safety and effectiveness features, components and hardware requirements and has the same intended uses as the Dejarnette Imageshare Film Digitizer Acquisition Gateway, the Lumisys DICOM Toolkit, and the RadWorks Medical Imaging Software.

**Summary of Studies:** In addition to system design verification tests to assure conformance with the design specifications, the design has or will undergo further validation to assure overall user satisfaction.

**Conclusion:** Intended uses and basic system design, including the hardware, are similar to products manufactured by other companies. The features of this product are the same as those available on other legally marketed products. Therefore, it is the opinion of GE Medical Systems that the GE Advantage Digitizer Workstation is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.