(77 days)
The GF: 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.
The GE Advantage Windows Review Workstation consists of a Sun Microsystems Spare 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).
This document is a 510(k) summary for a GE Medical Systems device modification (K960613). It focuses on the GE Advantage Windows Review Workstation. Based on the provided text, the document describes a device modification and primarily discusses its substantial equivalence to previously cleared devices.
Crucially, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any of the detailed study specifics requested in your prompt.
The "Summary of Studies" section only states: "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." This indicates that design verification tests were done to meet specifications and that further validation for user satisfaction was planned or ongoing. It does not provide any detailed results or acceptance criteria relating to clinical performance.
Therefore, I cannot populate the requested sections based on the provided text. The document is a regulatory submission focused on demonstrating substantial equivalence, not a detailed technical or clinical study report.
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GE Medical Systems
PO Box 414. Milwaukee. WI 53201
APR 3 0 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.
Legally marketed devices include the Advantage CT/MR Radiology Diagnostic Marketed Devices: 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 Spare 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 GF: 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 GH 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.
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).