510(k) clearance

EZFluence (RADEZ V2)

FDA 510(k) source

510(k) number

K261718

Applicant

Radformation, Inc.

Decision date

Aug 31, 2026

Date received

May 26, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

IYE

Device type

Accelerator, Linear, Medical

Device class

Class II

Regulation

21 CFR 892.5050

Advisory committee

Radiology

Statement or summary

Summary

Third party

N

Location

New York, NY, US