# K171352: EZFluence

- Pathway: 510(k) (Traditional)
- Applicant: Radformation, Inc.
- Decided: Dec 1, 2017 after 206 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: 12 generations back to K010975 (2001). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152393: Eclipse Treatment Planning System, Varian Medical Systems, Inc. (2015) Summary page 5.

## Most influential descendants
- K261718: EZFluence (RADEZ V2) (2026), 0 descendants of its own

## Indications for use
EZFluence 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/K171352
Methodology: https://510kreport.com/methodology