510(k) · Cleared
Recalled · Class II · 2013Advantage Workstation 4.3.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare · LLZ System, Image Processing, Radiological
Cleared on Nov 8, 2005 as substantially equivalent to K020483 (GE Medical Systems, 2002) and 1 other predicate after a 14-day review. Its family tree reaches back 3 generations to 1991. 113 later devices descend from it. It has been recalled 4 times.
- Decided
- Nov 8, 2005
- Review
- 14 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 3 generations to K913770 (1991). 10 ancestors in all, the oldest K871859 (1987). 113 later devices descend from it, 8 citing it directly.
- Root · 3 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 2 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 1 generation backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- This deviceK052995 Advantage Workstation 4.3.GE Healthcare · 2005
- Descendant · cites it directly · 65 of its ownK092639 Innova Vision, Model S18751VN, Innova Trackvision, Model S18751VT…GE Medical Systems SCS · 2009
- Descendant · 2 generations on · 41 of its ownK101311 EP Navigator R3Philips Medical Systems North America Co. · 2010
- Descendant · 3 generations on · 39 of its ownK111245 Heartnavigator Release 1Philips Medical Systems Nederland B.V. · 2011
- Descendant · 4 generations on · 32 of its ownK121781 Echonavigator Release 1Philips Medical Systems Nederland B.V. · 2012
- Descendant · 5 generations on · 28 of its ownK172607 Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic…Philips Health Care · 2017 · Recalled
Showing 5 of 113 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 113 · See all- K092639Innova Vision, Model S18751VN, Innova Trackvision, Model S18751VT, Innova Epvision…GE Medical Systems SCS · 2009 · cites it directly65descendants
- K101311EP Navigator R3Philips Medical Systems North America Co. · 2010 · 2 generations on41descendants
- K111245Heartnavigator Release 1Philips Medical Systems Nederland B.V. · 2011 · 3 generations on39descendants
- K121781Echonavigator Release 1Philips Medical Systems Nederland B.V. · 2012 · 4 generations on32descendants
- K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care · 2017 · 5 generations on28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −2 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −1 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| 0 (this device) | K052995 | Advantage Workstation 4.3. | GE Healthcare | 2005 | — |
| +1 | K092639 | Innova Vision, Model S18751VN, Innova Trackvision, Model S18751VT, Innova… | GE Medical Systems SCS | 2009 | — |
| +2 | K101311 | EP Navigator R3 | Philips Medical Systems North America Co. | 2010 | — |
| +3 | K111245 | Heartnavigator Release 1 | Philips Medical Systems Nederland B.V. | 2011 | — |
| +4 | K121781 | Echonavigator Release 1 | Philips Medical Systems Nederland B.V. | 2012 | — |
| +5 | K172607 | Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound… | Philips Health Care | 2017 | 31 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 5 | 0 |
| 2014 | 6 | 0 |
| 2015 | 8 | 0 |
| 2016 | 5 | 0 |
| 2017 | 5 | 0 |
| 2018 | 7 | 0 |
| 2020 | 10 | 0 |
| 2021 | 8 | 0 |
| 2022 | 8 | 0 |
| 2023 | 6 | 0 |
| 2024 | 10 | 0 |
| 2025 | 12 | 0 |
| 2026 | 9 | 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 |
|---|---|---|---|
| * | K020483 | Advantage Workstation 4.1Summary page 1…ices The Advantage Workstation is substantially equivalent to the devices listed below: * Model: Advantage Workstation 4.1. 5 10(k) # K020483 * Manufacturer: General Electric Medical Systems, Buc, France * Model: Volume Viewer… | 2002 |
| * | K041521 | Volume Viewer PlusSummary page 1…on 4.1. 5 10(k) # K020483 * Manufacturer: General Electric Medical Systems, Buc, France * Model: Volume Viewer Plus, 5 10(k) #K041521 * Manufacturer: General Electric Medical Systems, Buc, France IDevice Description: AW 4.3 is a multi-… | 2004 |
What descends from it? (113)
See all 1138 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092639 | Innova Vision, Model S18751VN, Innova Trackvision, Model S18751VT, Innova Epvision… | 2009 | 65 |
| K081985 | AW Server | 2008 | 27 |
| K110834 | AW Volumeshare 5 with Angioviz Option | 2011 | 13 |
| K071000 | Myrian | 2007 | 8 |
| K091001 | Myrian 1.4 | 2009 | 7 |
| K061587 | Fullcard Analysis | 2006 | 1 |
| K060453 | Aze Virtualplace | 2006 | 1 |
| K090552 | Urocare | 2009 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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… |
| May 24, 2012 | Class II | Z-2203-2012 | Software design | 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 aorta analysis protocol or the… |
| May 31, 2011 | Not classified | Z-3012-2011 | Software design | 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 workstation is synchronized with RIS… |
| Sep 10, 2007 | Not classified | Z-0265-2008 | Software design | 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 customized protocols for an aneurysm should… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- 4 of the 10 ancestors have a recall of any class.
- Of its descendants, K092639 (GE Medical Systems SCS, 2009) has gone furthest, with 65 descendants of its own.
- 4 other devices also cite its predicate K020483.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052995 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052995: Advantage Workstation 4.3..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052995
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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