# K182966: PLANET Onco Dose

- Pathway: 510(k) (Traditional)
- Applicant: Dosisoft
- Decided: Mar 6, 2019 after 131 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K954874 (1996). 72 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173636: Velocity, Varian Medical Systems, Inc. (2018) Summary page 5.

## Most influential descendants
- K241765: PLANET Onco Dose (3.2) (2025), 0 descendants of its own

## Indications for use
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

Source page: https://510kreport.com/device/K182966
Methodology: https://510kreport.com/methodology