# K131862: 3DVH

- Pathway: 510(k) (Traditional)
- Applicant: Sun Nuclear Corporation
- Decided: Aug 21, 2013 after 58 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K914698 (1992). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072374: Compass, Scanditronix Wellhofer GmbH (2007) Summary page 1.

## Indications for use
Model 1212 3DVH is a radiotherapy dose delivery quality assurance (QA) software application intended to estimate the dosimetric impacts of the deviations and imperfections of a treatment delivery device, and its accessories, on the 3D patient dose volume as defined by a treatment planning system (TPS). These dosimetric impacts are based upon QA measurement of the radiation dose distributions that are delivered to a phantom.

Source page: https://510kreport.com/device/K131862
Methodology: https://510kreport.com/methodology