# K261718: EZFluence (RADEZ V2)

- Pathway: 510(k) (Traditional)
- Applicant: Radformation, Inc.
- Decided: Aug 31, 2026 after 97 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: 13 generations back to K010975 (2001). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171352: EZFluence, Radformation, Inc. (2017) Summary page 6.

## Indications for use
EZFluence (RADEZ V2) is intended to assist radiation treatment planning professionals in generating optimal fluences for producing a homogeneous dose distribution in external beam radiation therapy treatment plans consisting of photon treatment fields.

Source page: https://510kreport.com/device/K261718
Methodology: https://510kreport.com/methodology