510(k) · Cleared
ClearedHermes HD AQ Acquisition Station and Hermes Workstation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nuclear Diagnostics AB · LLZ System, Image Processing, Radiological
Cleared on Dec 5, 2000 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 97 later devices descend from it.
- Decided
- Dec 5, 2000
- Review
- 90 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 0
97 later devices descend from it, 5 citing it directly.
- This deviceK002782 Hermes HD AQ Acquisition Station and Hermes WorkstationNuclear Diagnostics AB · 2000
- Descendant · cites it directly · 93 of its ownK021656 Hermes Hdaq Acquisition Station and Hermes Workstation, Ver. 3.4Nuclear Diagnostics · 2002
- Descendant · 2 generations on · 90 of its ownK121074 Scenium 2.0Siemens Medical Solutions USA, Inc. · 2012
- Descendant · 2 generations on · 79 of its ownK123528 SceniumSiemens Medical Solutions USA, Inc. · 2012
- Descendant · 2 generations on · 77 of its ownK130884 Xeleris 3.1 Processing and Review WorkstationGe Medical Systems F.I. Haifa · 2013
- Descendant · 3 generations on · 60 of its ownK153355 Xeleris 4.0 Processing and Review WorkstationGE Healthcare · 2016
Showing 5 of 97 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 97 · See all- K021656Hermes Hdaq Acquisition Station and Hermes Workstation, Ver. 3.4Nuclear Diagnostics · 2002 · cites it directly93descendants
- K121074Scenium 2.0Siemens Medical Solutions USA, Inc. · 2012 · 2 generations on90descendants
- K123528SceniumSiemens Medical Solutions USA, Inc. · 2012 · 2 generations on79descendants
- K130884Xeleris 3.1 Processing and Review WorkstationGe Medical Systems F.I. Haifa · 2013 · 2 generations on77descendants
- K153355Xeleris 4.0 Processing and Review WorkstationGE Healthcare · 2016 · 3 generations on60descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K121074 | Scenium 2.0 | Siemens Medical Solutions USA, Inc. | 2012 | — |
| +2 | K123528 | Scenium | Siemens Medical Solutions USA, Inc. | 2012 | — |
| +2 | K130884 | Xeleris 3.1 Processing and Review Workstation | Ge Medical Systems F.I. Haifa | 2013 | — |
| +3 | K153355 | Xeleris 4.0 Processing and Review Workstation | GE Healthcare | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 7 | 0 |
| 2021 | 9 | 0 |
| 2022 | 10 | 0 |
| 2023 | 11 | 0 |
| 2024 | 10 | 0 |
| 2025 | 11 | 0 |
| 2026 | 11 | 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.
Planning a device in LLZ? 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (97)
See all 975 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?
- Of its descendants, K021656 (Nuclear Diagnostics, 2002) has gone furthest, with 93 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
https://510kreport.com/device/K002782 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002782: Hermes HD AQ Acquisition Station and Hermes Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002782
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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