510(k) · Cleared
ClearedSophy NXT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sopha Medical Systems, Inc. · KPS System, Tomography, Computed, Emission
Cleared on Dec 17, 1991 after a 126-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 415 devices in its family, counting itself, has a Class I recall. 414 later devices descend from it.
- Decided
- Dec 17, 1991
- Review
- 126 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 0
414 later devices descend from it, 1 citing it directly. 1 of the 415 devices in this family, counting this one, has a Class I recall.
- This deviceK913641 Sophy NXTSopha Medical Systems, Inc. · 1991
- Descendant · cites it directly · 413 of its ownK972886 MirageSegami Corp., Inc. · 1997
- Descendant · 2 generations on · 382 of its ownK041022 Neuroq - Pet DPSyntermed, Inc. · 2004
- Descendant · 3 generations on · 380 of its ownK042863 SceniumSiemens Molecular Imaging, Ltd. · 2004
- Descendant · 3 generations on · 350 of its ownK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- Descendant · 4 generations on · 287 of its ownK071964 Mim 4.1 (Seastar)Mimvista Corp. · 2007 · Recalled
Showing 5 of 414 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…10 generations on · 2025
Most influential descendants
Showing 5 of 414 · See all- K972886MirageSegami Corp., Inc. · 1997 · cites it directly413descendants
- K041022Neuroq - Pet DPSyntermed, Inc. · 2004 · 2 generations on382descendants
- K042863SceniumSiemens Molecular Imaging, Ltd. · 2004 · 3 generations on380descendants
- K060816Mim 4.0 (NeuroMimvista Corp. · 2006 · 3 generations on350descendants
- K071964Mim 4.1 (Seastar)Mimvista Corp. · 2007 · 4 generations on287descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K913641 | Sophy NXT | Sopha Medical Systems, Inc. | 1991 | — |
| +1 | K972886 | Mirage | Segami Corp., Inc. | 1997 | — |
| +2 | K041022 | Neuroq - Pet DP | Syntermed, Inc. | 2004 | — |
| +3 | K042863 | Scenium | Siemens Molecular Imaging, Ltd. | 2004 | — |
| +3 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| +4 | K071964 | Mim 4.1 (Seastar) | Mimvista Corp. | 2007 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 6 | 0 |
| 2007 | 7 | 0 |
| 2008 | 8 | 0 |
| 2009 | 3 | 0 |
| 2010 | 7 | 0 |
| 2011 | 9 | 0 |
| 2012 | 10 | 0 |
| 2013 | 9 | 0 |
| 2014 | 14 | 0 |
| 2015 | 13 | 0 |
| 2016 | 18 | 0 |
| 2017 | 18 | 0 |
| 2018 | 28 | 0 |
| 2019 | 24 | 0 |
| 2020 | 32 | 0 |
| 2021 | 27 | 0 |
| 2022 | 32 | 0 |
| 2023 | 34 | 0 |
| 2024 | 30 | 0 |
| 2025 | 42 | 1 |
| 2026 | 38 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (414)
See all 4141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K972886 | Mirage | 1997 | 413 |
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 · 10 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K972886 (Segami Corp., Inc., 1997) has gone furthest, with 413 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/K913641 · printed Nov 4, 2026
Cite this page
510(k) Report. “K913641: Sophy NXT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K913641
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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