510(k) Report

510(k) · Cleared

Cleared

Hermes Hdaq Acquisition Station and Hermes Workstation, Ver. 3.4

K021656510(k) SpecialCleared Jun 13, 200224-day reviewClass II21 CFR 892.1200

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Nuclear Diagnostics · KPS System, Tomography, Computed, Emission

Cleared on Jun 13, 2002 as substantially equivalent to K002782 (Nuclear Diagnostics AB, 2000) after a 24-day review. Its family tree reaches back 1 generation to 2000. 93 later devices descend from it.

Decided
Jun 13, 2002
Review
24 days
Class
Class II
Product code
KPS
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K002782 (2000). 93 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2012: 3 descendants cleared2013: 3 descendants cleared2014: 3 descendants cleared2021: 9 descendants cleared2018: 4 descendants cleared2016: 4 descendants cleared2015: 2 descendants cleared2017: 3 descendants cleared2020: 7 descendants cleared2024: 10 descendants cleared2022: 10 descendants cleared2019: 2 descendants cleared2023: 11 descendants cleared2026: 11 descendants cleared2025: 11 descendants clearedK002782 · Hermes HD AQ Acquisition Station and Hermes Workstation · Nuclear Diagnostics AB · 2000200020052010201520202025
Descendants, by generation 1 generation forward: 6 descendants2 generations forward: 10 descendants3 generations forward: 9 descendants4 generations forward: 15 descendants5 generations forward: 23 descendants6 generations forward: 13 descendants7 generations forward: 6 descendants8 generations forward: 4 descendants9 generations forward: 5 descendants10 generations forward: 1 descendant11 generations forward: 1 descendant K002782 · Hermes HD AQ Acquisition Station and Hermes Workstation · Nuclear Diagnostics AB · 20000+5+10
  1. Root · 1 generation backK002782 Hermes HD AQ Acquisition Station and Hermes WorkstationNuclear Diagnostics AB · 2000
  2. This deviceK021656 Hermes Hdaq Acquisition Station and Hermes Workstation, Ver. 3.4Nuclear Diagnostics · 2002
  3. Descendant · cites it directly · 90 of its ownK121074 Scenium 2.0Siemens Medical Solutions USA, Inc. · 2012
  4. Descendant · cites it directly · 79 of its ownK123528 SceniumSiemens Medical Solutions USA, Inc. · 2012
  5. Descendant · cites it directly · 77 of its ownK130884 Xeleris 3.1 Processing and Review WorkstationGe Medical Systems F.I. Haifa · 2013
  6. Descendant · 2 generations on · 60 of its ownK153355 Xeleris 4.0 Processing and Review WorkstationGE Healthcare · 2016
  7. Descendant · 3 generations on · 53 of its ownK182624 MIM - MRT DosimetryMim Software, Inc. · 2018

Showing 5 of 93 descendants. See all descendants

Descendants cleared per year

2012: 32013: 32014: 32015: 22016: 42017: 32018: 42019: 22020: 72021: 92022: 102023: 112024: 102025: 112026: 11
2012high 11 (2023) · low 2 (2015)2026

Most influential descendants

Showing 5 of 93 · See all
  • K121074Scenium 2.0Siemens Medical Solutions USA, Inc. · 2012 · cites it directly90descendants
  • K123528SceniumSiemens Medical Solutions USA, Inc. · 2012 · cites it directly79descendants
  • K130884Xeleris 3.1 Processing and Review WorkstationGe Medical Systems F.I. Haifa · 2013 · cites it directly77descendants
  • K153355Xeleris 4.0 Processing and Review WorkstationGE Healthcare · 2016 · 2 generations on60descendants
  • K182624MIM - MRT DosimetryMim Software, Inc. · 2018 · 3 generations on53descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K002782Hermes HD AQ Acquisition Station and Hermes WorkstationNuclear Diagnostics AB2000—
0 (this device)K021656Hermes Hdaq Acquisition Station and Hermes Workstation, Ver. 3.4Nuclear Diagnostics2002—
+1K121074Scenium 2.0Siemens Medical Solutions USA, Inc.2012—
+1K123528SceniumSiemens Medical Solutions USA, Inc.2012—
+1K130884Xeleris 3.1 Processing and Review WorkstationGe Medical Systems F.I. Haifa2013—
+2K153355Xeleris 4.0 Processing and Review WorkstationGE Healthcare2016—
+3K182624MIM - MRT DosimetryMim Software, Inc.2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201230
201330
201430
201520
201640
201730
201840
201920
202070
202190
2022100
2023110
2024100
2025110
2026110
FIG. 1 — Lineage of K021656, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K253564 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI…score 18.7 · 17 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K002782Hermes HD AQ Acquisition Station and Hermes Workstation
Summary page 1
…H E M E S HDAQ Acquisition Station and HERMES Workstation, Vcr. 3.4 is the same as the onc fur the HERMES HDAQ Acquisition Station and HERMES Workstation (K002782). The H E W E S system consists oftwo components, a data acquisition station and a computer workstation. The HERMES…
Nuclear Diagnostics AB2000—

Also cleared against K002782: 4 other devices →

What descends from it? (93)

See all 93

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K121074Scenium 2.0Siemens Medical Solutions USA, Inc.201290
K123528SceniumSiemens Medical Solutions USA, Inc.201279
K130884Xeleris 3.1 Processing and Review WorkstationGe Medical Systems F.I. Haifa201377
K121278Hermes Medical Imaging Suite V5.2Hermes Medical Solutions AB201218
K131233Hermes Medical Imaging Suite V5.3Hermes Medical Solutions AB201316
K140269Hermes Medical Imaging Suite V5.4Hermes Medical Solutions AB201415

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?

  • Its one ancestor has no recall.
  • Of its descendants, K121074 (Siemens Medical Solutions USA, Inc., 2012) has gone furthest, with 90 descendants of its own.
  • 4 other devices also cite its predicate K002782.

How does its category compare?

All KPS devices

KPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KPS

12in 2025

2007: 82008: 172009: 92010: 32011: 72012: 62013: 112014: 112015: 32016: 112017: 112018: 132019: 32020: 122021: 152022: 52023: 122024: 112025: 122026 (partial year): 6
2007high 17 (2008) · low 3 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KPS

65in 2025

2007: 38 days median2008: 25 days median2009: 42 days median2010: 91 days median2011: 28 days median2012: 94 days median2013: 84 days median2014: 92 days median2015: 112 days median2016: 65 days median2017: 104 days median2018: 59 days median2019: 60 days median2020: 72 days median2021: 66 days median2022: 60 days median2023: 63 days median2024: 59 days median2025: 65 days median2026 (partial year): 67 days median
2007high 112 (2015) · low 25 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KPS

16in 2025

2007: 222008: 162009: 142010: 42011: 342012: 132013: 132014: 182015: 52016: 162017: 112018: 12, 3 Class I2019: 5, 5 Class I2020: 82021: 42022: 8, 6 Class I2023: 6, 3 Class I2024: 152025: 162026 (partial year): 6
2007high 34 (2011) · low 4 (2010)2026

Class I (17 since 2007) Class II/III not classified

Adverse event reports per year · KPS

36in 2025

2007: 382008: 112009: 152010: 442011: 562012: 342013: 2402014: 332015: 242016: 102017: 312018: 262019: 1052020: 222021: 102022: 152023: 222024: 232025: 36
2007high 240 (2013) · low 10 (2016)2025

MAUDE reports naming product code KPS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20078382238
200817251611
20099421415
2010391444
20117283456
20126941334
2013118413240
201411921833
20153112524
201611651610
2017111041131
2018135912 (3)26
20193605 (5)105
20201272822
20211566410
20225608 (6)15
202312636 (3)22
202411591523
202512651636
20266676—

What is it indicated for?

The HERMES HDAQ Acquisition Station is a system designed to acquire nuclear medicine image data using a compatible gamma camera system. The HERMES Workstation is a system designed to process, display, analyze, and manage nuclear medicine and other medical imaging data transferred from other workstations or HDAQ acquisition stations.

Indications for use as stated in the FDA summary.

Also cleared against K002782

4 other devices cite the same predicate.

  • K131233Hermes Medical Imaging Suite V5.3Hermes Medical Solutions AB · 2013
  • K121278Hermes Medical Imaging Suite V5.2Hermes Medical Solutions AB · 2012
  • K111731Molecular Breast Imaging SoftwareGamma Medica-Ideas Incorporated · 2011
  • K021314Sceptre-VSHitachi Medical Systems America, Inc. · 2002

Recent decisions in KPS

The KPS category page

  • K261305Micsi-PetMicrostructure Imaging, Inc. · 2026
  • K261427uMI Panvivo (uMI Panvivo M)Shanghai United Imaging Healthcare Co., Ltd. · 2026
  • K261315Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia…Siemens Medical Solutions USA, Inc. · 2026
  • K260524uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI…Shanghai United Imaging Healthcare Co., Ltd. · 2026
  • K253564uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI…Shanghai United Imaging Healthcare Co., Ltd. · 2026

https://510kreport.com/device/K021656 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021656: Hermes Hdaq Acquisition Station and Hermes Workstation, Ver. 3.4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021656

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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