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 · QIH Automated Radiological Image Processing Software
Cleared on Jul 31, 2026 as substantially equivalent to K243919 (Hermes Medical Solutions AB, 2025) and 1 other predicate after a 242-day review. Its family tree reaches back 16 generations to 2001. 1 of the 112 devices in its family, counting itself, has a Class I recall.
- Decided
- Jul 31, 2026
- Review
- 242 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 16 generations to K010641 (2001). 111 ancestors in all, the oldest K885054 (1989). No later device cites it as a predicate yet. 1 of the 112 devices in this family, counting this one, has a Class I recall.
- Root · 16 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
- 12 generations between
- 3 generations backK171719 Hybrid3DHermes Medical Solutions AB · 2017
- 2 generations backK181468 Hybrid3DHermes Medical Solutions AB · 2018
- 1 generation backK202882 AffinityHermes Medical Solutions AB · 2020
- This deviceK253835 AffinityHermes Medical Solutions AB · 2026
Show all 16 generations
- Root · 16 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
- 15 generations backK023988 GE Discovery LS SystemGE Medical Systems · 2003 · Recalled
- 14 generations backK040172 Modification to GE Discovery LS SystemGE Medical Systems · 2004 · Recalled
- 13 generations backK041543 GE Discovery STGE Healthcare · 2004 · Recalled
- 12 generations backK042863 SceniumSiemens Molecular Imaging, Ltd. · 2004
- 11 generations backK061545 Scenium 1.1Siemens Molecular Imaging, Ltd. · 2006
- 10 generations backK121074 Scenium 2.0Siemens Medical Solutions USA, Inc. · 2012
- 9 generations backK123528 SceniumSiemens Medical Solutions USA, Inc. · 2012
- 8 generations backK130884 Xeleris 3.1 Processing and Review WorkstationGe Medical Systems F.I. Haifa · 2013
- 7 generations backK140269 Hermes Medical Imaging Suite V5.4Hermes Medical Solutions AB · 2014
- 6 generations backK142631 Hermes Medical Imaging Suite v5.5Hermes Medical Solutions AB · 2014
- 5 generations backK153056 Hermes Medical Imaging Suite v5.6Hermes Medical Solutions AB · 2016
- 4 generations backK163394 Hybrid3DHermes Medical Solutions AB · 2017
- 3 generations backK171719 Hybrid3DHermes Medical Solutions AB · 2017
- 2 generations backK181468 Hybrid3DHermes Medical Solutions AB · 2018
- 1 generation backK202882 AffinityHermes Medical Solutions AB · 2020
- This deviceK253835 AffinityHermes Medical Solutions AB · 2026
Class I recalls in this family
- K991841 Hawkeye Option for Dual-Head Variable Angle…6 generations back · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K010641 | GE CT-Pet System | Ge Medical Systems, Inc. | 2001 | — |
| −15 | K023988 | GE Discovery LS System | GE Medical Systems | 2003 | 1 |
| −14 | K040172 | Modification to GE Discovery LS System | GE Medical Systems | 2004 | 5 |
| −13 | K041543 | GE Discovery ST | GE Healthcare | 2004 | 1 |
| −12 | K042863 | Scenium | Siemens Molecular Imaging, Ltd. | 2004 | — |
| −11 | K061545 | Scenium 1.1 | Siemens Molecular Imaging, Ltd. | 2006 | — |
| −10 | K121074 | Scenium 2.0 | Siemens Medical Solutions USA, Inc. | 2012 | — |
| −9 | K123528 | Scenium | Siemens Medical Solutions USA, Inc. | 2012 | — |
| −8 | K130884 | Xeleris 3.1 Processing and Review Workstation | Ge Medical Systems F.I. Haifa | 2013 | — |
| −7 | K140269 | Hermes Medical Imaging Suite V5.4 | Hermes Medical Solutions AB | 2014 | — |
| −6 | K142631 | Hermes Medical Imaging Suite v5.5 | Hermes Medical Solutions AB | 2014 | — |
| −5 | K153056 | Hermes Medical Imaging Suite v5.6 | Hermes Medical Solutions AB | 2016 | — |
| −4 | K163394 | Hybrid3D | Hermes Medical Solutions AB | 2017 | — |
| −3 | K171719 | Hybrid3D | Hermes Medical Solutions AB | 2017 | — |
| −2 | K181468 | Hybrid3D | Hermes Medical Solutions AB | 2018 | — |
| −1 | K202882 | Affinity | Hermes Medical Solutions AB | 2020 | — |
| 0 (this device) | K253835 | Affinity | Hermes Medical Solutions AB | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 5 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 5 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 5 | 0 |
| 1999 | 4 | 1 |
| 2000 | 9 | 0 |
| 2001 | 5 | 0 |
| 2002 | 7 | 0 |
| 2003 | 4 | 0 |
| 2004 | 5 | 0 |
| 2005 | 6 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2025 | 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.
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 QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.5 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K243919 | Voxel Dosimetry (00859873006226)Summary page 5…LLZ, KPS PREDICATE DEVICES Primary Predicate Device Name: Voxel Dosimetry 510(k) number: K243919 Regulation Number: 21 CFR 892.2050 Product Codes: QIH… | 2025 |
| * | K202882 | AffinitySummary page 5…QIH LLZ Secondary Predicate Device Name: Affinity 510(k) number: K202882 Regulation Number: 21 CFR 892.1200 Product Code: KPS DEVICE… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- K991841Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999 · 6 generations back · ◆ in the 1999 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 25 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 31 of the 111 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K243919.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
Affinity displays, processes and analyzes nuclear medicine and radiology imaging data for investigation of physiological or pathological states. The functionality in Affinity is not intended to replace visual assessment by the intended user.
The information obtained from the images, including quantitative analysis, may be 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/K253835 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253835: Affinity.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253835
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026