510(k) · Cleared
ClearedPLANET Onco Dose
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dosisoft · LLZ System, Image Processing, Radiological
Cleared on Mar 6, 2019 as substantially equivalent to K173636 (Varian Medical Systems, Inc., 2018) after a 131-day review. Its family tree reaches back 13 generations to 1996. 1 later device descends from it.
- Decided
- Mar 6, 2019
- Review
- 131 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K954874 (1996). 72 ancestors in all, the oldest K871859 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 13 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 9 generations between
- 3 generations backK151913 MIM-Thin Client (mobile)Mim Software, Inc. · 2016
- 2 generations backK172218 MIM – Y90 DosimetryMim Software, Inc. · 2017
- 1 generation backK173636 VelocityVarian Medical Systems, Inc. · 2018
- This deviceK182966 PLANET Onco DoseDosisoft · 2019
- Descendant · cites it directly · 0 of its ownK241765 PLANET Onco Dose (3.2)Dosisoft SA · 2025
Show all 13 generations
- Root · 13 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 12 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 11 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 10 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 9 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 8 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 7 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 6 generations backK062163 MimviewerMimvista Corp. · 2006
- 5 generations backK103785 Mobile MimMim Software, Inc. · 2011
- 4 generations backK112930 Mobile MimMim Software, Inc. · 2011
- 3 generations backK151913 MIM-Thin Client (mobile)Mim Software, Inc. · 2016
- 2 generations backK172218 MIM – Y90 DosimetryMim Software, Inc. · 2017
- 1 generation backK173636 VelocityVarian Medical Systems, Inc. · 2018
- This deviceK182966 PLANET Onco DoseDosisoft · 2019
Most influential descendants
Showing 1 of 1 · See all- K241765PLANET Onco Dose (3.2)Dosisoft SA · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −12 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −11 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −10 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −9 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −8 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −7 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −6 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
| −5 | K103785 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −4 | K112930 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −3 | K151913 | MIM-Thin Client (mobile) | Mim Software, Inc. | 2016 | — |
| −2 | K172218 | MIM – Y90 Dosimetry | Mim Software, Inc. | 2017 | — |
| −1 | K173636 | Velocity | Varian Medical Systems, Inc. | 2018 | — |
| 0 (this device) | K182966 | PLANET Onco Dose | Dosisoft | 2019 | — |
| +1 | K241765 | PLANET Onco Dose (3.2) | Dosisoft SA | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 5 | 0 |
| 2001 | 7 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 6 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 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? (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 |
|---|---|---|---|
| * | K173636 | VelocitySummary page 5…System, Image Processing, Radiological (21 CFR 892.2050, Class II, Product Code LLZ) 4. Predicate Device: K173636 – Velocity – Varian Medical Systems, Inc. Executive Summary 5. Product Description: PLANET Onco Dose is a software platform ded… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241765 | PLANET Onco Dose (3.2) | 2025 | 0 |
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 23 years and passes through 7 companies; a new generation was cleared every 1.6 years on median.
- 18 of the 72 ancestors have a recall of any class.
- Of its descendants, K241765 (Dosisoft SA, 2025) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K173636.
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?
PLANET Onco Dose is a standalone software intended to be used with PET or SPECT hybrid imaging systems in order to manage, process, display and analyze nuclear medicine and other digital medical image series, to assist in medical diagnosis, to assist in treatment analysis and in therapy response assessment, to assist in the contouring of region of interest for radiotherapy. PLANET Onco Dose is dedicated to be used by qualified medical professionals in…
Read the full statement (428 words)
PLANET Onco Dose is a standalone software intended to be used with PET or SPECT hybrid imaging systems in order to manage, process, display and analyze nuclear medicine and other digital medical image series, to assist in medical diagnosis, to assist in treatment analysis and in therapy response assessment, to assist in the contouring of region of interest for radiotherapy.
PLANET Onco Dose is dedicated to be used by qualified medical professionals in Molecular Imaging, and/or Medical Oncology.
The medical modalities of these medical imaging systems include CT, MRI, SPECT, PET, XA, RT Struct and RT Dose as supported by ACR/NEMA DICOM 3 standard format.
PLANET Onco Dose provides the user with the means to segment structures in medical image volumes by providing dedicated delineation, contouring and propagation tools for both tumors and normal tissues (i.e. Regions of Interest (ROI)).
PLANET Onco Dose provides tools to display, co-register (including deformable registration), compute Standardized Uptake Value (SUV) and import / export results (contours and dosimetries) to / from Treatment Planning Systems (TPS) and PACS devices for assessment and response of patients undergoing a course of oncology treatment.
PLANET Onco Dose provides the user with the means to assist in the assessment quantification and verification of radiation doses received by tissues as a result of administering a radionuclide (e.g. Permanent Yttrium-90 microsphere implants).
PLANET Onco Dose provides tools for post-treatment absorbed dose calculation and evaluation on PET and SPECT images. The following functions are available to allow dose calculations for patients after they have received a treatment using permanent Yttrium-90 (Y90) microspheres:
- 3D liver-lung shunt assessment;
- Local Deposition Model;
- Voxel S Value approach based on the schema in MIRD Pamphlet 17 [1];
- Dosimetry based on 90Y-microspheres-PET (or SPECT Bremsstrahlung) series;
- Compatible with PET images acquired with another radioisotope instead of Y90 when Y90 acquisitions are not supported by the scanner (correction of branching ratio and decay parameters).
For Y90 microspheres, PLANET Onco Dose cannot be used to prescribe the radionuclide activity to be administered to the patient for the therapy. The user has to provide the radionuclide parameters (e.g. activity) in order for PLANET Onco Dose to estimate the radiation doses that the tissues received as a result of the administration.
PLANET Onco Dose should only be used for the retrospective determination of dose and not for the case where there is a need for retreatment using Y90 microspheres.
[1] Bolch WE et al. MIRD pamphlet no. 17: the dosimetry of nonuniform activity distributions-Radionuclide S values at the voxel level. J Nucl Med, 1999, 40:11S-36S
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182966 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182966: PLANET Onco Dose.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182966
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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