510(k) · Cleared
Cleared3D-RD-S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radiopharmaceutical Imaging & Dosimetry, LLC · LLZ System, Image Processing, Radiological
Cleared on Sep 4, 2026 as substantially equivalent to K243919 (Hermes Medical Solutions AB, 2025) after a 78-day review. Its family tree reaches back 16 generations to 1996. 1 of the 103 devices in its family, counting itself, has a Class I recall.
- Decided
- Sep 4, 2026
- Review
- 78 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K954874 (1996). 102 ancestors in all, the oldest K885054 (1989). No later device cites it as a predicate yet. 1 of the 103 devices in this family, counting this one, has a Class I recall.
- Root · 16 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 12 generations between
- 3 generations backK182624 MIM - MRT DosimetryMim Software, Inc. · 2018
- 2 generations backK191216 Voxel Dosimetry™ v1.0Hermes Medical Solutions AB · 2019
- 1 generation backK243919 Voxel Dosimetry (00859873006226)Hermes Medical Solutions AB · 2025
- This deviceK262060 3D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC · 2026
Show all 16 generations
- Root · 16 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 15 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 14 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 13 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 12 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 11 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 10 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 9 generations backK062163 MimviewerMimvista Corp. · 2006
- 8 generations backK103785 Mobile MimMim Software, Inc. · 2011
- 7 generations backK112930 Mobile MimMim Software, Inc. · 2011
- 6 generations backK151913 MIM-Thin Client (mobile)Mim Software, Inc. · 2016
- 5 generations backK172218 MIM – Y90 DosimetryMim Software, Inc. · 2017
- 4 generations backK180815 MIM - SPECTRA QuantMim Software, Inc. · 2018
- 3 generations backK182624 MIM - MRT DosimetryMim Software, Inc. · 2018
- 2 generations backK191216 Voxel Dosimetry™ v1.0Hermes Medical Solutions AB · 2019
- 1 generation backK243919 Voxel Dosimetry (00859873006226)Hermes Medical Solutions AB · 2025
- This deviceK262060 3D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC · 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 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −15 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −14 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −13 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −12 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −11 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −10 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −9 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
| −8 | K103785 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −7 | K112930 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −6 | K151913 | MIM-Thin Client (mobile) | Mim Software, Inc. | 2016 | — |
| −5 | K172218 | MIM – Y90 Dosimetry | Mim Software, Inc. | 2017 | — |
| −4 | K180815 | MIM - SPECTRA Quant | Mim Software, Inc. | 2018 | — |
| −3 | K182624 | MIM - MRT Dosimetry | Mim Software, Inc. | 2018 | — |
| −2 | K191216 | Voxel Dosimetry™ v1.0 | Hermes Medical Solutions AB | 2019 | — |
| −1 | K243919 | Voxel Dosimetry (00859873006226) | Hermes Medical Solutions AB | 2025 | — |
| 0 (this device) | K262060 | 3D-RD-S | Radiopharmaceutical Imaging & Dosimetry, LLC | 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 | 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 |
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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K243919 | Voxel Dosimetry (00859873006226)Summary page 5…Product Code: LLZ Device Class: Class II 4. Predicate Device Trade Name: Voxel Dosimetry Manufacturer: Hermes Medical Solutions AB 510(k) number: K243919 Radiopharmaceutical Imaging & Dosimetry, LLC Page 1 of 4 5. D… | 2025 |
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 30 years and passes through 7 companies; a new generation was cleared every 1.6 years on median.
- 31 of the 102 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 LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
3D-RD-S is intended to estimate radiation absorbed dose (and related quantities) to tissues after administration of a radioactive product. For use with internally administered radioactive products, 3D-RD-S should not be used to deviate from product dosing and administration instructions. Refer to the product's prescribing information for instructions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K262060 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262060: 3D-RD-S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262060
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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