510(k) · Cleared
Recalled · Class II · 2013AW Volumeshare 5 with Angioviz Option
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 Apr 26, 2011 as substantially equivalent to K052995 (GE Healthcare, 2005) after a 32-day review. Its family tree reaches back 4 generations to 1991. 13 later devices descend from it. It has been recalled once.
- Decided
- Apr 26, 2011
- Review
- 32 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K913770 (1991). 11 ancestors in all, the oldest K871859 (1987). 13 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 3 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 2 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 1 generation backK052995 Advantage Workstation 4.3.GE Healthcare · 2005 · Recalled
- This deviceK110834 AW Volumeshare 5 with Angioviz OptionGE Healthcare · 2011
- Descendant · cites it directly · 6 of its ownK142736 XIDF-AWS801, Angio Workstation, v5.31Toshibamedical Systems Corporation · 2015
- Descendant · 2 generations on · 5 of its ownK150967 XIDF-AWS801, Angio Workstation, V6.10Toshibamedical Systems Corporation · 2015 · Recalled
- Descendant · 3 generations on · 4 of its ownK152785 XIDF-AWS801, Angio Workstation, V6.20Toshibamedical Systems Corporation · 2015 · Recalled
- Descendant · 4 generations on · 3 of its ownK172646 XIDF-AWS801, Angio Workstation, V7.0Toshibamedical Systems Corporation · 2017
- Descendant · 5 generations on · 2 of its ownK181415 XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0Canon Medical Systems Corporation · 2018
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K142736XIDF-AWS801, Angio Workstation, v5.31Toshibamedical Systems Corporation · 2015 · cites it directly6descendants
- K150967XIDF-AWS801, Angio Workstation, V6.10Toshibamedical Systems Corporation · 2015 · 2 generations on5descendants
- K152785XIDF-AWS801, Angio Workstation, V6.20Toshibamedical Systems Corporation · 2015 · 3 generations on4descendants
- K172646XIDF-AWS801, Angio Workstation, V7.0Toshibamedical Systems Corporation · 2017 · 4 generations on3descendants
- K181415XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0Canon Medical Systems Corporation · 2018 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −3 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −2 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −1 | K052995 | Advantage Workstation 4.3. | GE Healthcare | 2005 | 4 |
| 0 (this device) | K110834 | AW Volumeshare 5 with Angioviz Option | GE Healthcare | 2011 | — |
| +1 | K142736 | XIDF-AWS801, Angio Workstation, v5.31 | Toshibamedical Systems Corporation | 2015 | — |
| +2 | K150967 | XIDF-AWS801, Angio Workstation, V6.10 | Toshibamedical Systems Corporation | 2015 | 1 |
| +3 | K152785 | XIDF-AWS801, Angio Workstation, V6.20 | Toshibamedical Systems Corporation | 2015 | 1 |
| +4 | K172646 | XIDF-AWS801, Angio Workstation, V7.0 | Toshibamedical Systems Corporation | 2017 | — |
| +5 | K181415 | XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0 | Canon Medical Systems Corporation | 2018 | — |
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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 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? (1)
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 1…Classification Name: 21CFR 892.2050 Picture archiving and communications system Product Code: LLZ7 Predicate Devices: Advantage Workstation 4.3 1K052995) DeieDescription: The AW VolumeShare 5 isa stand-alone workstation with its own Deviceimage database r… | 2005 |
What descends from it? (13)
See all 133 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 |
|---|---|---|---|---|
| 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… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- 5 of the 11 ancestors have a recall of any class.
- Of its descendants, K142736 (Toshibamedical Systems Corporation, 2015) has gone furthest, with 6 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. 2011, 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 VolumeShare 5 is a review workstation, 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 of diagnosis, except in the case of mammography images. AngioViz is an application which produces from a OSA series parametric images representing maximum opacification…
Read the full statement (114 words)
AW VolumeShare 5 is a review workstation, 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 of diagnosis, except in the case of mammography images.
AngioViz is an application which produces from a OSA series parametric images representing maximum opacification, time to peak and combinations of those, to enable the user to more easily visualize characteristics related to vascular flow.
The AngioViz application can be used to process USA image data from any location in the human body for which USA imaging is used.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110834 · printed Nov 5, 2026
Cite this page
510(k) Report. “K110834: AW Volumeshare 5 with Angioviz Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110834
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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