510(k) · Cleared
Recalled · Class II · 2012Advantage Windows CT/Pet Fusion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems, Inc. · LLZ System, Image Processing, Radiological
Cleared on Feb 16, 2001 after an 11-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 495 devices in its family, counting itself, has a Class I recall. 494 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 16, 2001
- Review
- 11 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 2
- Predicates
- 0
494 later devices descend from it, 9 citing it directly. 1 of the 495 devices in this family, counting this one, has a Class I recall.
- This deviceK010336 Advantage Windows CT/Pet FusionGe Medical Systems, Inc. · 2001
- Descendant · cites it directly · 442 of its ownK020546 Fusion 7DMirada Solutions, Ltd. · 2002
- Descendant · cites it directly · 222 of its ownK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
- Descendant · 2 generations on · 221 of its ownK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- Descendant · 2 generations on · 201 of its ownK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- Descendant · 3 generations on · 200 of its ownK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
Showing 5 of 494 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…7 generations on · 2025
Most influential descendants
Showing 5 of 494 · See all- K020546Fusion 7DMirada Solutions, Ltd. · 2002 · cites it directly442descendants
- K041484UndecidedSiemens Medical Solutions USA, Inc. · 2004 · cites it directly222descendants
- K053301Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006 · 2 generations on221descendants
- K071950Syngo TruedSiemens Medical Solutions USA, Inc. · 2007 · 2 generations on201descendants
- K091373Syngo TruedSiemens Medical Solutions USA, Inc. · 2009 · 3 generations on200descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010336 | Advantage Windows CT/Pet Fusion | Ge Medical Systems, Inc. | 2001 | — |
| +1 | K020546 | Fusion 7D | Mirada Solutions, Ltd. | 2002 | — |
| +1 | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
| +2 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| +2 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| +3 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 5 | 0 |
| 2005 | 5 | 0 |
| 2006 | 9 | 0 |
| 2007 | 10 | 0 |
| 2008 | 10 | 0 |
| 2009 | 14 | 0 |
| 2010 | 8 | 0 |
| 2011 | 8 | 0 |
| 2012 | 20 | 0 |
| 2013 | 13 | 0 |
| 2014 | 16 | 0 |
| 2015 | 19 | 0 |
| 2016 | 19 | 0 |
| 2017 | 22 | 0 |
| 2018 | 29 | 0 |
| 2019 | 29 | 0 |
| 2020 | 32 | 0 |
| 2021 | 26 | 0 |
| 2022 | 35 | 0 |
| 2023 | 35 | 0 |
| 2024 | 37 | 0 |
| 2025 | 51 | 1 |
| 2026 | 39 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (494)
See all 4949 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020546 | Fusion 7D | 2002 | 442 |
| K041484 | Undecided | 2004 | 222 |
| K070248 | Velocityais | 2007 | 65 |
| K081076 | Velocityais, Velocity AI, Velocityvx, Velocityrt, V-Response | 2008 | 63 |
| K061370 | Cardiq Fusion | 2006 | 51 |
| K052345 | Advantage Sim MD | 2005 | 21 |
| K100881 | Synapse Obliquus Mip/MPR/Fusion | 2010 | 1 |
| K022310 | Advantage Windows X-Ray/MR Fusion | 2002 | 1 |
| K093234 | Integrated Registration | 2009 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 24, 2012 | Class II | Z-1960-2012 | Software design | GE Healthcare has become aware of a potential safety issue due to incorrect alignment of fused CT and PET images associated with the CT/PET fusion capabilities of your Volume Viewer and CT/PET Fusion application. Volume Viewer allows two… |
| Oct 8, 2004 | Not classified | Z-0854-06 | Other | Display in fused mode- viewer allows 2 studies ( PET/CT) registered in the same spatial domain to be viewed simultaneously. These 2 images should be visually aligned to a precision of less than 1/2 PET Voxel. A problem associated with… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 7 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K020546 (Mirada Solutions, Ltd., 2002) has gone furthest, with 442 descendants of its own.
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 | — |
https://510kreport.com/device/K010336 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010336: Advantage Windows CT/Pet Fusion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010336
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026