# K092928: Dose Volume Histogram (DVH) Evaluator

- Pathway: 510(k) (Traditional)
- Applicant: Diversilabs, LLC
- Decided: Dec 16, 2009 after 84 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- 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: 7 generations back to K010975 (2001). 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)
- K000478: The Cyberknife System for Stereotactic Radiosurgery/ Radiotherapy V2.1, Accuray, Inc. (2000) Summary page 2.
- K091492: Modification to Eclipse Treatment Planning System, Varian Medical Systems, Inc. (2009) Summary page 2.

## Indications for use
The DiversiLabs Dose Volume Histogram (DVH) Evaluator is intended to aid with comparing radiation therapy treatment plans to applicable dose tolerance limits, and for recording followup patient response and symptoms.

Source page: https://510kreport.com/device/K092928
Methodology: https://510kreport.com/methodology