510(k) · Cleared
Recalled · Class II · 2026AW Server
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems, LLC · LLZ System, Image Processing, Radiological
Cleared on Sep 25, 2008 as substantially equivalent to K052995 (GE Healthcare, 2005) and 1 other predicate after a 73-day review. Its family tree reaches back 4 generations to 1995. 27 later devices descend from it. It has been recalled 5 times.
- Decided
- Sep 25, 2008
- Review
- 73 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 4 generations to K945188 (1995). 16 ancestors in all, the oldest K871859 (1987). 27 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK945188 Cemax Vipstation and/or SoftwareCemax, Inc. · 1995
- 3 generations backK961023 Aidp (Accuimage Image Display Processor)Accuimage, Inc. · 1996
- 2 generations backK994329 Iivs Integrated Image Viewing StationTerarecon,Inc. · 2000
- 1 generation backK012086 Aquariusnet ServerTerarecon,Inc. · 2001
- This deviceK081985 AW ServerGe Medical Systems, LLC · 2008
- Descendant · cites it directly · 12 of its ownK150193 Customer Remote Console (CRC)Ge Medical Systems, LLC · 2015
- Descendant · cites it directly · 6 of its ownK113620 Myrian 1.11Intrasense · 2012
- Descendant · 2 generations on · 4 of its ownK232744 syngo Virtual Cockpit (VB10A)Siemens Healthcare GmbH · 2023
- Descendant · 2 generations on · 4 of its ownK200179 Collaboration LivePhilips Health Care · 2020
- Descendant · cites it directly · 3 of its ownK111642 Onco Trac Model 1, 2, 4Translational Sciences Corporation · 2011
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K150193Customer Remote Console (CRC)Ge Medical Systems, LLC · 2015 · cites it directly12descendants
- K113620Myrian 1.11Intrasense · 2012 · cites it directly6descendants
- K232744syngo Virtual Cockpit (VB10A)Siemens Healthcare GmbH · 2023 · 2 generations on4descendants
- K200179Collaboration LivePhilips Health Care · 2020 · 2 generations on4descendants
- K111642Onco Trac Model 1, 2, 4Translational Sciences Corporation · 2011 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K945188 | Cemax Vipstation and/or Software | Cemax, Inc. | 1995 | — |
| −3 | K961023 | Aidp (Accuimage Image Display Processor) | Accuimage, Inc. | 1996 | — |
| −2 | K994329 | Iivs Integrated Image Viewing Station | Terarecon,Inc. | 2000 | — |
| −1 | K012086 | Aquariusnet Server | Terarecon,Inc. | 2001 | — |
| 0 (this device) | K081985 | AW Server | Ge Medical Systems, LLC | 2008 | — |
| +1 | K150193 | Customer Remote Console (CRC) | Ge Medical Systems, LLC | 2015 | — |
| +1 | K113620 | Myrian 1.11 | Intrasense | 2012 | — |
| +2 | K232744 | syngo Virtual Cockpit (VB10A) | Siemens Healthcare GmbH | 2023 | — |
| +2 | K200179 | Collaboration Live | Philips Health Care | 2020 | — |
| +1 | K111642 | Onco Trac Model 1, 2, 4 | Translational Sciences Corporation | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 5 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K052995 | Advantage Workstation 4.3.Summary page 3…valent to that of the following devices: Device Name FDA Clearance Number Advantage Workstation 4.3 K052995 AquariusNET Server K012086 7. Adverse Effects on Health The potential hazards are identifi… | 2005 |
| * | K012086 | Aquariusnet ServerSummary page 3…me FDA Clearance Number Advantage Workstation 4.3 K052995 AquariusNET Server K012086 7. Adverse Effects on Health The potential hazards are identified in a risk management summary (hazard analysis) and are… | 2001 |
What descends from it? (27)
See all 275 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 8, 2026 | Class II | Z-2553-2026 | Software design | 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 application (e.g. Volume Viewer), the… |
| Sep 5, 2025 | Class II | Z-0068-2026 | Software in the Use Environment | 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 | Software design | 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 Server when making a batch and rotating… |
| Jun 28, 2012 | Class II | Z-1137-2013 | Software design | 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 pixel and certain annotation data from a… |
| Nov 17, 2011 | Not classified | Z-0486-2012 | Software design | 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 application is starting, the second… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 5 of the 16 ancestors have a recall of any class.
- Of its descendants, K150193 (Ge Medical Systems, LLC, 2015) has gone furthest, with 12 descendants of its own.
- 7 other devices also cite its predicate K052995.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
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…
Read the full statement (107 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081985 · printed Nov 3, 2026
Cite this page
510(k) Report. “K081985: AW Server.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K081985
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026