510(k) · Cleared
ClearedHybrid Viewer (00859873006240)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hermes Medical Solutions AB · KPS System, Tomography, Computed, Emission
Cleared on Sep 9, 2025 as substantially equivalent to K241364 (Hermes Medical Solutions AB, 2024) after a 33-day review. Its family tree reaches back 14 generations to 2001.
- Decided
- Sep 9, 2025
- Review
- 33 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K010641 (2001). 29 ancestors in all, the oldest K914350 (1991). No later device cites it as a predicate yet.
- Root · 14 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
- 10 generations between
- 3 generations backK153056 Hermes Medical Imaging Suite v5.6Hermes Medical Solutions AB · 2016
- 2 generations backK171681 Hermes Medical Imaging Suite v5.7Hermes Medical Solutions AB · 2017 · Recalled
- 1 generation backK241364 Hybrid Viewer (00859873006189)Hermes Medical Solutions AB · 2024
- This deviceK252477 Hybrid Viewer (00859873006240)Hermes Medical Solutions AB · 2025
Show all 14 generations
- Root · 14 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
- 13 generations backK023988 GE Discovery LS SystemGE Medical Systems · 2003 · Recalled
- 12 generations backK040172 Modification to GE Discovery LS SystemGE Medical Systems · 2004 · Recalled
- 11 generations backK041543 GE Discovery STGE Healthcare · 2004 · Recalled
- 10 generations backK042863 SceniumSiemens Molecular Imaging, Ltd. · 2004
- 9 generations backK061545 Scenium 1.1Siemens Molecular Imaging, Ltd. · 2006
- 8 generations backK121074 Scenium 2.0Siemens Medical Solutions USA, Inc. · 2012
- 7 generations backK123528 SceniumSiemens Medical Solutions USA, Inc. · 2012
- 6 generations backK130884 Xeleris 3.1 Processing and Review WorkstationGe Medical Systems F.I. Haifa · 2013
- 5 generations backK140269 Hermes Medical Imaging Suite V5.4Hermes Medical Solutions AB · 2014
- 4 generations backK142631 Hermes Medical Imaging Suite v5.5Hermes Medical Solutions AB · 2014
- 3 generations backK153056 Hermes Medical Imaging Suite v5.6Hermes Medical Solutions AB · 2016
- 2 generations backK171681 Hermes Medical Imaging Suite v5.7Hermes Medical Solutions AB · 2017 · Recalled
- 1 generation backK241364 Hybrid Viewer (00859873006189)Hermes Medical Solutions AB · 2024
- This deviceK252477 Hybrid Viewer (00859873006240)Hermes Medical Solutions AB · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K010641 | GE CT-Pet System | Ge Medical Systems, Inc. | 2001 | — |
| −13 | K023988 | GE Discovery LS System | GE Medical Systems | 2003 | 1 |
| −12 | K040172 | Modification to GE Discovery LS System | GE Medical Systems | 2004 | 5 |
| −11 | K041543 | GE Discovery ST | GE Healthcare | 2004 | 1 |
| −10 | K042863 | Scenium | Siemens Molecular Imaging, Ltd. | 2004 | — |
| −9 | K061545 | Scenium 1.1 | Siemens Molecular Imaging, Ltd. | 2006 | — |
| −8 | K121074 | Scenium 2.0 | Siemens Medical Solutions USA, Inc. | 2012 | — |
| −7 | K123528 | Scenium | Siemens Medical Solutions USA, Inc. | 2012 | — |
| −6 | K130884 | Xeleris 3.1 Processing and Review Workstation | Ge Medical Systems F.I. Haifa | 2013 | — |
| −5 | K140269 | Hermes Medical Imaging Suite V5.4 | Hermes Medical Solutions AB | 2014 | — |
| −4 | K142631 | Hermes Medical Imaging Suite v5.5 | Hermes Medical Solutions AB | 2014 | — |
| −3 | K153056 | Hermes Medical Imaging Suite v5.6 | Hermes Medical Solutions AB | 2016 | — |
| −2 | K171681 | Hermes Medical Imaging Suite v5.7 | Hermes Medical Solutions AB | 2017 | 1 |
| −1 | K241364 | Hybrid Viewer (00859873006189) | Hermes Medical Solutions AB | 2024 | — |
| 0 (this device) | K252477 | Hybrid Viewer (00859873006240) | Hermes Medical Solutions AB | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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 KPS? 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? (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 |
|---|---|---|---|
| * | K241364 | Hybrid Viewer (00859873006189)Summary page 5…CFR 892.1200 Product Code: KPS PREDICATE DEVICE Predicate Device Name: Hybrid Viewer 510(k) number: K241364 Regulation Number: 21 CFR 892.1200 Product Code: KPS Product: Hybrid Viewer… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 8 of the 29 ancestors have a recall of any class.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
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 | — |
What is it indicated for?
Hybrid Viewer is a software application for nuclear medicine and radiology. Based on user input, Hybrid Viewer processes, displays and analyzes nuclear medicine and radiology imaging data and presents the results to the user. The results can be stored for future analysis. Hybrid Viewer is equipped with dedicated workflows which have predefined settings and layouts optimized for specific nuclear medicine investigations. The software application can be…
Read the full statement (119 words)
Hybrid Viewer is a software application for nuclear medicine and radiology. Based on user input, Hybrid Viewer processes, displays and analyzes nuclear medicine and radiology imaging data and presents the results to the user. The results can be stored for future analysis.
Hybrid Viewer is equipped with dedicated workflows which have predefined settings and layouts optimized for specific nuclear medicine investigations.
The software application can be configured based on user needs.
The investigation of physiological or pathological states using measurement and analysis functionality provided by Hybrid Viewer is not intended to replace visual assessment. The information obtained from viewing and/or performing quantitative analysis on the images is used, in conjunction with other patient related data, to inform clinical management.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252477 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252477: Hybrid Viewer (00859873006240).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252477
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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