510(k) · Cleared
ClearedVoxel Dosimetry™ v1.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hermes Medical Solutions AB · LLZ System, Image Processing, Radiological
Cleared on Oct 17, 2019 as substantially equivalent to K182624 (Mim Software, Inc., 2018) and 1 other predicate after a 164-day review. Its family tree reaches back 14 generations to 1996. 1 of the 106 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Oct 17, 2019
- Review
- 164 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K954874 (1996). 100 ancestors in all, the oldest K885054 (1989). 5 later devices descend from it, 2 citing it directly. 1 of the 106 devices in this family, counting this one, has a Class I recall.
- Root · 14 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 10 generations between
- 3 generations backK172218 MIM – Y90 DosimetryMim Software, Inc. · 2017
- 2 generations backK180815 MIM - SPECTRA QuantMim Software, Inc. · 2018
- 1 generation backK182624 MIM - MRT DosimetryMim Software, Inc. · 2018
- This deviceK191216 Voxel Dosimetry™ v1.0Hermes Medical Solutions AB · 2019
- Descendant · cites it directly · 2 of its ownK243919 Voxel Dosimetry (00859873006226)Hermes Medical Solutions AB · 2025
- Descendant · cites it directly · 1 of its ownK220630 TorchTM SoftwareVoximetry, Incorporated · 2022
- Descendant · 2 generations on · 0 of its ownK262060 3D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK253835 AffinityHermes Medical Solutions AB · 2026
- Descendant · 2 generations on · 0 of its ownK241765 PLANET Onco Dose (3.2)Dosisoft SA · 2025
Show all 14 generations
- Root · 14 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 13 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 12 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 11 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 10 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 9 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 8 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 7 generations backK062163 MimviewerMimvista Corp. · 2006
- 6 generations backK103785 Mobile MimMim Software, Inc. · 2011
- 5 generations backK112930 Mobile MimMim Software, Inc. · 2011
- 4 generations backK151913 MIM-Thin Client (mobile)Mim Software, Inc. · 2016
- 3 generations backK172218 MIM – Y90 DosimetryMim Software, Inc. · 2017
- 2 generations backK180815 MIM - SPECTRA QuantMim Software, Inc. · 2018
- 1 generation backK182624 MIM - MRT DosimetryMim Software, Inc. · 2018
- This deviceK191216 Voxel Dosimetry™ v1.0Hermes Medical Solutions AB · 2019
Class I recalls in this family
- K991841 Hawkeye Option for Dual-Head Variable Angle…4 generations back · 1999
Most influential descendants
Showing 5 of 5 · See all- K243919Voxel Dosimetry (00859873006226)Hermes Medical Solutions AB · 2025 · cites it directly2descendants
- K220630TorchTM SoftwareVoximetry, Incorporated · 2022 · cites it directly1descendant
- K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC · 2026 · 2 generations on0descendants
- K253835AffinityHermes Medical Solutions AB · 2026 · 2 generations on0descendants
- K241765PLANET Onco Dose (3.2)Dosisoft SA · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −13 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −12 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −11 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −10 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −9 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −8 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −7 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
| −6 | K103785 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −5 | K112930 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −4 | K151913 | MIM-Thin Client (mobile) | Mim Software, Inc. | 2016 | — |
| −3 | K172218 | MIM – Y90 Dosimetry | Mim Software, Inc. | 2017 | — |
| −2 | K180815 | MIM - SPECTRA Quant | Mim Software, Inc. | 2018 | — |
| −1 | K182624 | MIM - MRT Dosimetry | Mim Software, Inc. | 2018 | — |
| 0 (this device) | K191216 | Voxel Dosimetry™ v1.0 | Hermes Medical Solutions AB | 2019 | — |
| +1 | K243919 | Voxel Dosimetry (00859873006226) | Hermes Medical Solutions AB | 2025 | — |
| +1 | K220630 | TorchTM Software | Voximetry, Incorporated | 2022 | — |
| +2 | K262060 | 3D-RD-S | Radiopharmaceutical Imaging & Dosimetry, LLC | 2026 | — |
| +2 | K253835 | Affinity | Hermes Medical Solutions AB | 2026 | — |
| +2 | K241765 | PLANET Onco Dose (3.2) | Dosisoft SA | 2025 | — |
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 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 1 |
| 2000 | 9 | 0 |
| 2001 | 6 | 0 |
| 2002 | 6 | 0 |
| 2003 | 5 | 0 |
| 2004 | 7 | 0 |
| 2005 | 5 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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 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? (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 |
|---|---|---|---|
| * | K182624 | MIM - MRT DosimetrySummary page 4…system, Class II, 21CFR892.2050. D. Legally marketed device (predicate device): Following legally marketed device has been used for comparison. • MIM-MRT Dosimetry (K182624) • OLINDA/EXM® v2.0 (K163687) E. Description of the device that is subject of this premarket notification: Voxel Dosimetry™… | 2018 |
| * | K163687 | Olinda ExmSummary page 4…D. Legally marketed device (predicate device): Following legally marketed device has been used for comparison. • MIM-MRT Dosimetry (K182624) • OLINDA/EXM® v2.0 (K163687) E. Description of the device that is subject of this premarket notification: Voxel Dosimetry™ is a tool for voxel level absorbe… | 2017 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 4 generations back · ◆ in the 1999 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 23 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 31 of the 100 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K243919 (Hermes Medical Solutions AB, 2025) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K182624.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The intended use of Voxel Dosimetry™ is to provide estimates (deterministic) of absorbed radiation dose at voxel level as a result of administering one of the supported radionuclides and to provide a dose map. This is dependent on input data regarding bio distribution being supplied to the application.
Voxel Dosimetry™ only allows voxel-based dose calculations for patients who have been administered with radioisotopes.
Warning! The Voxel Dosimetry™ js only intended for calculating dose for FDA approved radiopharmaceuticals for any clinical purpose, and calculation of unapproved drugs can only be used for research purpose.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K191216 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191216: Voxel Dosimetry™ v1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191216
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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