510(k) · Cleared
ClearedAffinity
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 Dec 23, 2020 as substantially equivalent to K181468 (Hermes Medical Solutions AB, 2018) after an 86-day review. Its family tree reaches back 15 generations to 2001. 1 later device descends from it.
- Decided
- Dec 23, 2020
- Review
- 86 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K010641 (2001). 30 ancestors in all, the oldest K914350 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 15 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
- 11 generations between
- 3 generations backK163394 Hybrid3DHermes Medical Solutions AB · 2017
- 2 generations backK171719 Hybrid3DHermes Medical Solutions AB · 2017
- 1 generation backK181468 Hybrid3DHermes Medical Solutions AB · 2018
- This deviceK202882 AffinityHermes Medical Solutions AB · 2020
- Descendant · cites it directly · 0 of its ownK253835 AffinityHermes Medical Solutions AB · 2026
Show all 15 generations
- Root · 15 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
- 14 generations backK023988 GE Discovery LS SystemGE Medical Systems · 2003 · Recalled
- 13 generations backK040172 Modification to GE Discovery LS SystemGE Medical Systems · 2004 · Recalled
- 12 generations backK041543 GE Discovery STGE Healthcare · 2004 · Recalled
- 11 generations backK042863 SceniumSiemens Molecular Imaging, Ltd. · 2004
- 10 generations backK061545 Scenium 1.1Siemens Molecular Imaging, Ltd. · 2006
- 9 generations backK121074 Scenium 2.0Siemens Medical Solutions USA, Inc. · 2012
- 8 generations backK123528 SceniumSiemens Medical Solutions USA, Inc. · 2012
- 7 generations backK130884 Xeleris 3.1 Processing and Review WorkstationGe Medical Systems F.I. Haifa · 2013
- 6 generations backK140269 Hermes Medical Imaging Suite V5.4Hermes Medical Solutions AB · 2014
- 5 generations backK142631 Hermes Medical Imaging Suite v5.5Hermes Medical Solutions AB · 2014
- 4 generations backK153056 Hermes Medical Imaging Suite v5.6Hermes Medical Solutions AB · 2016
- 3 generations backK163394 Hybrid3DHermes Medical Solutions AB · 2017
- 2 generations backK171719 Hybrid3DHermes Medical Solutions AB · 2017
- 1 generation backK181468 Hybrid3DHermes Medical Solutions AB · 2018
- This deviceK202882 AffinityHermes Medical Solutions AB · 2020
Most influential descendants
Showing 1 of 1 · See all- K253835AffinityHermes Medical Solutions AB · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K010641 | GE CT-Pet System | Ge Medical Systems, Inc. | 2001 | — |
| −14 | K023988 | GE Discovery LS System | GE Medical Systems | 2003 | 1 |
| −13 | K040172 | Modification to GE Discovery LS System | GE Medical Systems | 2004 | 5 |
| −12 | K041543 | GE Discovery ST | GE Healthcare | 2004 | 1 |
| −11 | K042863 | Scenium | Siemens Molecular Imaging, Ltd. | 2004 | — |
| −10 | K061545 | Scenium 1.1 | Siemens Molecular Imaging, Ltd. | 2006 | — |
| −9 | K121074 | Scenium 2.0 | Siemens Medical Solutions USA, Inc. | 2012 | — |
| −8 | K123528 | Scenium | Siemens Medical Solutions USA, Inc. | 2012 | — |
| −7 | K130884 | Xeleris 3.1 Processing and Review Workstation | Ge Medical Systems F.I. Haifa | 2013 | — |
| −6 | K140269 | Hermes Medical Imaging Suite V5.4 | Hermes Medical Solutions AB | 2014 | — |
| −5 | K142631 | Hermes Medical Imaging Suite v5.5 | Hermes Medical Solutions AB | 2014 | — |
| −4 | K153056 | Hermes Medical Imaging Suite v5.6 | Hermes Medical Solutions AB | 2016 | — |
| −3 | K163394 | Hybrid3D | Hermes Medical Solutions AB | 2017 | — |
| −2 | K171719 | Hybrid3D | Hermes Medical Solutions AB | 2017 | — |
| −1 | K181468 | Hybrid3D | Hermes Medical Solutions AB | 2018 | — |
| 0 (this device) | K202882 | Affinity | Hermes Medical Solutions AB | 2020 | — |
| +1 | K253835 | Affinity | Hermes Medical Solutions AB | 2026 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 |
|---|---|---|---|
| * | K181468 | Hybrid3DSummary page 4…y System, Class II, 21CFR892.1200 D. Legally marketed device (predicate device): The following legally marketed device have been used for comparison. • Hybrid3D (K181468) - primary E. Description of the device that is subject of this premarket notification: Affinity can process data as whole body… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253835 | Affinity | 2026 | 0 |
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 19 years and passes through 7 companies; a new generation was cleared every 12 months on median.
- 7 of the 30 ancestors have a recall of any class.
- Of its descendants, K253835 (Hermes Medical Solutions AB, 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K181468.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
AFFINITY is a software application used to process, display, analyse and manage nuclear medicine and other medical imaging data transferred from other workstations, PACS or acquisition stations. The information acquired from viewing the images is used, in conjunction with other patient related data, for diagnosis and monitoring of disease.
Warning! This application is not intended to replace visual assessment of tumors. The primary purpose of the application is to provide pre-selection of lesions for visual confirmation and to provide consistency and reproducibility when assessing tumor response to treatment
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202882 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202882: Affinity.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202882
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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