510(k) · Cleared
ClearedHermes Medical Imaging Suite V5.2
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 18, 2012 as substantially equivalent to K002782 (Nuclear Diagnostics AB, 2000) and 1 other predicate after a 232-day review. Its family tree reaches back 2 generations to 2000. 18 later devices descend from it.
- Decided
- Dec 18, 2012
- Review
- 232 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K002782 (2000). 18 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK002782 Hermes HD AQ Acquisition Station and Hermes WorkstationNuclear Diagnostics AB · 2000
- 1 generation backK021656 Hermes Hdaq Acquisition Station and Hermes Workstation, Ver. 3.4Nuclear Diagnostics · 2002
- This deviceK121278 Hermes Medical Imaging Suite V5.2Hermes Medical Solutions AB · 2012
- Descendant · cites it directly · 16 of its ownK131233 Hermes Medical Imaging Suite V5.3Hermes Medical Solutions AB · 2013
- Descendant · 2 generations on · 15 of its ownK140269 Hermes Medical Imaging Suite V5.4Hermes Medical Solutions AB · 2014
- Descendant · 2 generations on · 11 of its ownK142631 Hermes Medical Imaging Suite v5.5Hermes Medical Solutions AB · 2014
- Descendant · 2 generations on · 10 of its ownK153056 Hermes Medical Imaging Suite v5.6Hermes Medical Solutions AB · 2016
- Descendant · 3 generations on · 6 of its ownK163394 Hybrid3DHermes Medical Solutions AB · 2017
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K131233Hermes Medical Imaging Suite V5.3Hermes Medical Solutions AB · 2013 · cites it directly16descendants
- K140269Hermes Medical Imaging Suite V5.4Hermes Medical Solutions AB · 2014 · 2 generations on15descendants
- K142631Hermes Medical Imaging Suite v5.5Hermes Medical Solutions AB · 2014 · 2 generations on11descendants
- K153056Hermes Medical Imaging Suite v5.6Hermes Medical Solutions AB · 2016 · 2 generations on10descendants
- K163394Hybrid3DHermes Medical Solutions AB · 2017 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002782 | Hermes HD AQ Acquisition Station and Hermes Workstation | Nuclear Diagnostics AB | 2000 | — |
| −1 | K021656 | Hermes Hdaq Acquisition Station and Hermes Workstation, Ver. 3.4 | Nuclear Diagnostics | 2002 | — |
| 0 (this device) | K121278 | Hermes Medical Imaging Suite V5.2 | Hermes Medical Solutions AB | 2012 | — |
| +1 | K131233 | Hermes Medical Imaging Suite V5.3 | Hermes Medical Solutions AB | 2013 | — |
| +2 | K140269 | Hermes Medical Imaging Suite V5.4 | Hermes Medical Solutions AB | 2014 | — |
| +2 | K142631 | Hermes Medical Imaging Suite v5.5 | Hermes Medical Solutions AB | 2014 | — |
| +2 | K153056 | Hermes Medical Imaging Suite v5.6 | Hermes Medical Solutions AB | 2016 | — |
| +3 | K163394 | Hybrid3D | Hermes Medical Solutions AB | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K002782 | Hermes HD AQ Acquisition Station and Hermes WorkstationSummary page 1…f the device that is subject of this premarket notification: The base product design .of Hermes Medical Imaging Suite is the same as for the Hermes Workstation (K021656, K002782), except thatisome third party applications and the, acquisition ATTACHMENT 3… | 2000 |
| * | K021656 | Hermes Hdaq Acquisition Station and Hermes Workstation, Ver. 3.4Summary page 1…ices has been used for comparison. *HERMES HDAQ Acquisition Station and Hermes Workstation (1<002782) *HERMES HDAQ Acquisition Station and Hermes Workstation (K021656) *ecam computer / esoft workstation (KO?3190) *Xeleris 2 processing and review workstation.(K051673) E. Description o… | 2002 |
| † | K023190 | E.Cam Computer / E.Soft Workstation | 2002 |
| † | K051673 | Xeleris 2 Processing and Review Workstation | 2005 |
What descends from it? (18)
See all 182 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 12 years and passes through 3 companies; a new generation was cleared every 10.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K131233 (Hermes Medical Solutions AB, 2013) has gone furthest, with 16 descendants of its own.
- 4 other devices also cite its predicate K002782.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
HERMES Medical Imaging suite that provides software applications used to process, display, analyze and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121278 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121278: Hermes Medical Imaging Suite V5.2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121278
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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