(82 days)
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No
The description focuses on film digitizing, DICOM conversion, and basic image viewing/annotation, with no mention of AI or ML terms or functionalities.
No
The device is described as a film digitizing and DICOM converting quality assurance workstation used for viewing and annotating images, not for treating any medical condition or directly impacting patient health.
No
The device is described as a "film digitizing and DICOM converting quality assurance (QA) workstation that permits viewing and annotation changes of digitized images prior to lossless storage or transmission." It processes images for archival and transmission, not for medical diagnosis. It does not analyze or interpret images to provide clinical findings or aid in disease detection.
No
The device description explicitly states it consists of a PC computer, keyboard, mouse, monitor, and a film digitizer in addition to the application software. This indicates it is a hardware and software system, not software-only.
Based on the provided information, the GE Advantage Digitizer Workstation is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The GE Advantage Digitizer Workstation's intended use is to digitize medical film images, convert them to DICOM format, and allow for viewing and annotation. It processes existing medical images, not biological samples.
- Lack of Biological Sample Processing: There is no mention of the device interacting with or analyzing any biological samples.
The device is clearly focused on the handling and management of medical images, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / 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.
Product codes
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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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 892.2020 Medical image communications device.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
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Image /page/0/Picture/0 description: The image shows a black and white drawing of a cartoon character's face. The character has large, round eyes and a wide smile. The drawing is simple and lacks detail, with the character's features being the main focus.
GE Medical Systems
General Electric Company
P.O. Box 414, Mihenuhee. WI 53201
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 |
ેવુસાં, 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.