GE ADVANTAGE WINDOWS REVIEW WORKSTATION

K960613 · GE Medical Systems · LLZ · Apr 30, 1996 · Radiology

Device Facts

• Record ID: K960613
• Device Name: GE ADVANTAGE WINDOWS REVIEW WORKSTATION
• Applicant: GE Medical Systems
• Product Code: LLZ · Radiology
• Decision Date: Apr 30, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The GE Advantage Windows Review Workstation is a two dimensional review station which allows selection and review of DICOM images from Computed Tomography (CT), Magnetic Resonance (MR), X-Ray (XR), Computed Radiography (CR) and Secondary Capture (SC) modalities.

Device Story

Workstation for review of medical images; inputs DICOM data from CT, MR, XR, CR, and SC modalities via Ethernet or ATM network; hardware platform utilizes Sun Microsystems Sparc 4, 5, 20, or UltraSparc Unix architecture; software application enables image selection and 2D visualization on color landscape or high-resolution monochrome monitors; used by radiologists and clinicians in clinical settings; facilitates diagnostic review and clinical decision-making by providing access to multi-modality imaging data.

Clinical Evidence

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

Technological Characteristics

Hardware: Sun Microsystems Sparc 4, 5, 20, or UltraSparc Unix workstation; 32-128 MB RAM; 1-4 GB mass storage; Ethernet/ATM networking; color landscape or high-resolution monochrome monitors. Software: GE Advantage Windows application. Connectivity: DICOM standard.

Indications for Use

Indicated for clinicians requiring selection and review of 2D DICOM images from CT, MR, XR, CR, and SC modalities.

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

• Advantage CT/MR Radiology Diagnostic Workstation (K913770)
• Advantage Windows Diagnostic X-Ray Workstation (K942120)

Submission Summary (Full Text)

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G

960613

GE Medical Systems

General Electric Company
P.O. Box 414, Milwaukee, WI 53201

APR 30 1996

# 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
Manager, Regulatory Programs
414-544-3894

**Date Prepared:**
February 12, 1996

**Product Identification:** GE Advantage Windows Review Workstation. This is a device modification.

**Marketed Devices:** Legally marketed devices include the Advantage CT/MR Radiology Diagnostic Workstation (K913770) manufactured by GE Medical Systems and the Advantage Windows Diagnostic X-Ray Workstation (K942120) also manufactured by GE Medical Systems.

**Device Description:** The GE Advantage Windows Review Workstation consists of a Sun Microsystems Sparc 4, 5, 20 or UltraSparc Unix workstation or equivalent with 32 to 128 MBytes of RAM, 1 to 4 GBytes of mass storage memory, an Ethernet or ATM networking interface and 1 to 4 color landscape or high resolution monochrome monitors. The GE Advantage Review Windows software application is designed and produced by GE Medical Systems. Earlier versions of this software were included in previous 510(k) Premarket Notification submissions (K913770, K942120).

**Indications for Use:** The GE Advantage Windows Review Workstation is a two dimensional review station which allows selection and review of DICOM images from Computed Tomography (CT), Magnetic Resonance (MR), X-Ray (XR), Computed Radiography (CR) and Secondary Capture (SC) modalities.

**Comparison with Predicate Device:** The GE Advantage Windows Review Workstation is comparable in key safety and effectiveness features, uses similar design, construction, and materials, and has the same intended uses as the GE Medical Systems Advantage CT/MR Radiology Diagnostic Workstation (K913770) and the GE Medical Systems Advantage Windows Diagnostic X-Ray Workstation (K942120).

**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:** The design and development of the modification conforms with relevant FDA Standards. Therefore, it is the opinion of GE Medical Systems that the GE Advantage Windows Review Workstation modification is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.