# K081985: AW Server

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Sep 25, 2008 after 73 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K945188 (1995). 16 ancestors in all.
27 later devices descend from it; 5 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052995: Advantage Workstation 4.3., GE Healthcare (2005) Summary page 3.
- K012086: Aquariusnet Server, Terarecon,Inc. (2001) Summary page 3.

## Most influential descendants
- K150193: Customer Remote Console (CRC) (2015), 12 descendants of its own
- K113620: Myrian 1.11 (2012), 6 descendants of its own
- K232744: syngo Virtual Cockpit (VB10A) (2023), 4 descendants of its own
- K200179: Collaboration Live (2020), 4 descendants of its own
- K111642: Onco Trac Model 1, 2, 4 (2011), 3 descendants of its own

## Recalls of this device
- May 8, 2026 · Class II · Z-2553-2026: GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches an interactive appl
- Sep 5, 2025 · Class II · Z-0068-2026: Firm has identified a security vulnerability in AW Server products. If exploited, a malicious actor could compromise the confidentiality, integrity, and availability of patient data.
- 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
- Jun 28, 2012 · Class II · Z-1137-2013: GE Healthcare has recently become aware of a potential safety issue with respect to the Results Viewer in the AW Server. After starting the Results Viewer with the selected series of a patient, the pi
- Nov 17, 2011 · Not classified · Z-0486-2012: 2 Unrelated Software Issues: An incorrect patient name maybe displayed when switching between two Volume Viewer tabs with different patients. Also, if a second patient exam is selected while the appli

## Indications for use
AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications. The device is not intended for diagnosis of mammography images. The device is not intended for diagnosis of lossy compressed images. For other images, trained physicians may use the images as a basis for diagnosis upon ensuring that monitor quality, ambient light conditions and image compression ratios are consistent with clinical application.

Source page: https://510kreport.com/device/K081985
Methodology: https://510kreport.com/methodology