# K052995: Advantage Workstation 4.3.

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Nov 8, 2005 after 14 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K913770 (1991). 10 ancestors in all.
113 later devices descend from it; 8 cite it directly.
0 of 124 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020483: Advantage Workstation 4.1, GE Medical Systems (2002) Summary page 1.
- K041521: Volume Viewer Plus, General Electric Medical Systems (2004) Summary page 1.

## Most influential descendants
- K092639: Innova Vision, Model S18751VN, Innova Trackvision, Model S18751VT, Innova Epvision, Model S18751EP (2009), 65 descendants of its own
- K101311: EP Navigator R3 (2010), 41 descendants of its own
- K111245: Heartnavigator Release 1 (2011), 39 descendants of its own
- K121781: Echonavigator Release 1 (2012), 32 descendants of its own
- K172607: Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System (2017), 28 descendants of its own

## Recalls of this device
- Sep 19, 2013 · Class II · Z-0270-2014: GE Healthcare has recently become aware of a potential safety issue due to the image orientation within GSI viewer on AW products. The GSI Viewer application running on AW/Volume Share or on the AW Se
- May 24, 2012 · Class II · Z-2203-2012: GE Healthcare is informing you of incorrect measurements when using the Aorta analysis protocol or customized protocols. Until a new software version is installed they are asking you not to use the ao
- May 31, 2011 · Not classified · Z-3012-2011: GE Healthcare has become aware that patient mismatch could occur on some Seno Advantage 2.1 and 2.2 Workstations with RIS CCOW integration. This issue may impact patient safety. When Seno Advantage wo
- Sep 10, 2007 · Not classified · Z-0265-2008: Aortic Length over-estimated: incorrect measurements when using the Aorta analysis protocol or customized protocols. Until a new software version is installed the aorta analysis protocol or the custom

## Indications for use
Advantage Workstation 4.3 is a review station, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis for diagnosis, except in the case of mammography images.

Source page: https://510kreport.com/device/K052995
Methodology: https://510kreport.com/methodology