# K033400: Seno Advantage

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems W-400
- Decided: Dec 4, 2003 after 41 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 6 (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). 4 ancestors in all.
637 later devices descend from it; 9 cite it directly.
1 of 642 devices in its family (counting itself) has 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.

## Most influential descendants
- K043415: Centricity Pacs System (2005), 324 descendants of its own
- K071964: Mim 4.1 (Seastar) (2007), 287 descendants of its own
- K043216: Cadstream Version 4.0 (2005), 263 descendants of its own
- K091373: Syngo Trued (2009), 200 descendants of its own
- K050846: B-Cad System, Version 1.0 (2005), 123 descendants of its own

## Recalls of this device
- Sep 20, 2012 · Class II · Z-2257-2013: GE Healthcare has recently become aware that patient mismatch without a warning message could occur on Seno Advantage (SA) workstations under certain circumstances. This issue may impact patient safet
- May 24, 2012 · Class II · Z-0095-2013: GE Healthcare has become aware of an issue associated with the magnification images acquired on non-GE digital mammography systems and your Seno Advantage Workstation that may impact patient safety. T
- May 24, 2012 · Class II · Z-0125-2013: GE Healthcare has recently become aware of inaccurate Scale factor annotation provided by SenoAdvantage 2.2 workstations that may impact patient safety. This issue may result in a potential miscalcula
- 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
- Feb 9, 2010 · Not classified · Z-1747-2010: GE Healthcare has recently become aware of inaccurate Scale factor annotation provided by SenoAdvantage 2.2 workstations that may impact patient safety. When using the Print Image or Print Screen feat
- Aug 28, 2009 · Not classified · Z-0476-2011: The measurement values provided by the GE Workstation may be incorrect when applied to magnification images acquired on non-GE digital mammography systems. If not noticed by the caregiver, this could 

## Indications for use
Seno Advantage is a medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. When interpreted by a trained physician, mammographic images displayed on the high-resolution monitors may be used as an element for diagnosis. Furthermore filmed images from all modalities may also be used as an element for diagnosis.

Source page: https://510kreport.com/device/K033400
Methodology: https://510kreport.com/methodology