(77 days)
No
The document describes a standard image review workstation with no mention of AI or ML capabilities, image processing beyond basic review, or performance studies related to algorithmic performance.
No
The device is described as a two-dimensional review station for DICOM images from various modalities, intended for selection and review, rather than for direct therapeutic intervention or treatment.
No
The device is described as a "review station" that allows selection and review of DICOM images. Its predicate devices are listed as "Diagnostic Workstations." While it is used in the context of diagnostic imaging, its specific function described is review, not direct diagnosis. The information provided does not indicate that the device itself performs medical diagnosis; rather, it facilitates the review of images that a human diagnostician would interpret.
No
The device description explicitly states it consists of hardware components (Sun Microsystems workstation, RAM, mass storage, networking interface, monitors) in addition to the software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the selection and review of medical images from various imaging modalities (CT, MR, X-Ray, CR, SC). This is a function related to medical imaging interpretation and review, not the examination of specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description details a workstation with hardware and software for image review. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD-related terms: There are no mentions of specimens, assays, reagents, or any other terms typically associated with in vitro diagnostics.
The device is clearly described as a medical image review workstation, which falls under the category of medical devices used for diagnostic imaging interpretation.
N/A
Intended Use / 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.
Product codes
Not Found
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT), Magnetic Resonance (MR), X-Ray (XR), Computed Radiography (CR) and Secondary Capture (SC)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular shape. The letters are stylized and have a classic, vintage appearance, and the logo is black and white.
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.