510(k) · Cleared
ClearedAdvance Analysis Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Electric Co. · KPS System, Tomography, Computed, Emission
Cleared on Nov 29, 1994 after a 260-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 479 devices in its family, counting itself, has a Class I recall. 478 later devices descend from it.
- Decided
- Nov 29, 1994
- Review
- 260 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 0
478 later devices descend from it, 1 citing it directly. 1 of the 479 devices in this family, counting this one, has a Class I recall.
- This deviceK941223 Advance Analysis SoftwareGeneral Electric Co. · 1994
- Descendant · cites it directly · 477 of its ownK983256 Advantage Windows (AW) FusionGE Medical Systems · 1998
- Descendant · 2 generations on · 442 of its ownK020546 Fusion 7DMirada Solutions, Ltd. · 2002
- Descendant · 2 generations on · 204 of its ownK063324 Pet VcarGE Healthcare · 2007 · Recalled
- Descendant · 3 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 478 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…8 generations on · 2025
Most influential descendants
Showing 5 of 478 · See all- K983256Advantage Windows (AW) FusionGE Medical Systems · 1998 · cites it directly477descendants
- K020546Fusion 7DMirada Solutions, Ltd. · 2002 · 2 generations on442descendants
- K063324Pet VcarGE Healthcare · 2007 · 2 generations on204descendants
- K071950Syngo TruedSiemens Medical Solutions USA, Inc. · 2007 · 3 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) | K941223 | Advance Analysis Software | General Electric Co. | 1994 | — |
| +1 | K983256 | Advantage Windows (AW) Fusion | GE Medical Systems | 1998 | — |
| +2 | K020546 | Fusion 7D | Mirada Solutions, Ltd. | 2002 | — |
| +2 | K063324 | Pet Vcar | GE Healthcare | 2007 | 1 |
| +3 | 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 |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 4 | 0 |
| 2006 | 7 | 0 |
| 2007 | 9 | 0 |
| 2008 | 8 | 0 |
| 2009 | 17 | 0 |
| 2010 | 7 | 0 |
| 2011 | 9 | 0 |
| 2012 | 22 | 0 |
| 2013 | 11 | 0 |
| 2014 | 18 | 0 |
| 2015 | 19 | 0 |
| 2016 | 16 | 0 |
| 2017 | 23 | 0 |
| 2018 | 28 | 0 |
| 2019 | 24 | 0 |
| 2020 | 32 | 0 |
| 2021 | 25 | 0 |
| 2022 | 34 | 0 |
| 2023 | 34 | 0 |
| 2024 | 36 | 0 |
| 2025 | 46 | 1 |
| 2026 | 37 | 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 KPS device
- #1 K253564 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI…score 18.6 · 17 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? (478)
See all 4781 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K983256 | Advantage Windows (AW) Fusion | 1998 | 477 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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 · 8 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K983256 (GE Medical Systems, 1998) has gone furthest, with 477 descendants of its own.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KPS
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPS
65in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPS
16in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · KPS
36in 2025
MAUDE reports naming product code KPS, 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 | 8 | 38 | 22 | 38 |
| 2008 | 17 | 25 | 16 | 11 |
| 2009 | 9 | 42 | 14 | 15 |
| 2010 | 3 | 91 | 4 | 44 |
| 2011 | 7 | 28 | 34 | 56 |
| 2012 | 6 | 94 | 13 | 34 |
| 2013 | 11 | 84 | 13 | 240 |
| 2014 | 11 | 92 | 18 | 33 |
| 2015 | 3 | 112 | 5 | 24 |
| 2016 | 11 | 65 | 16 | 10 |
| 2017 | 11 | 104 | 11 | 31 |
| 2018 | 13 | 59 | 12 (3) | 26 |
| 2019 | 3 | 60 | 5 (5) | 105 |
| 2020 | 12 | 72 | 8 | 22 |
| 2021 | 15 | 66 | 4 | 10 |
| 2022 | 5 | 60 | 8 (6) | 15 |
| 2023 | 12 | 63 | 6 (3) | 22 |
| 2024 | 11 | 59 | 15 | 23 |
| 2025 | 12 | 65 | 16 | 36 |
| 2026 | 6 | 67 | 6 | — |
https://510kreport.com/device/K941223 · printed Nov 6, 2026
Cite this page
510(k) Report. “K941223: Advance Analysis Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K941223
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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