# K970628: GE Advantage Digitizer Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, Inc.
- Decided: May 12, 1997 after 82 days
- Product code: LMD (System, Digital Image Communications, Radiological)
- Device class: 1
- Regulation: 21 CFR 892.2020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Dejarnette Imageshare Film Digitizer Acquisition Gateway: named in the summary without a submission number
- (no number) Lumisys DICOM Toolkit: named in the summary without a submission number
- (no number) RadWorks Medical Imaging Software: named in the summary without a submission number

## 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.

Source page: https://510kreport.com/device/K970628
Methodology: https://510kreport.com/methodology