# K020483: Advantage Workstation 4.1

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Feb 28, 2002 after 15 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K913770 (1991). 3 ancestors in all.
872 later devices descend from it; 5 cite it directly.
1 of 876 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960613: GE Advantage Windows Review Workstation, GE Medical Systems (1996) Summary page 1.

## Most influential descendants
- K033400: Seno Advantage (2003), 637 descendants of its own
- 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

## Recalls of this device
- 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
- 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
The Advantage Workstation 4.1 is a review station, which allows easy selection, review, processing, filming and media interchange of multi-modality images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed images may be used as an element for diagnosis.

Source page: https://510kreport.com/device/K020483
Methodology: https://510kreport.com/methodology