EZFluence (RADEZ V2)— 510(k) K261718
Substantially EquivalentRadformation, Inc.
FDA 510(k) clearance K261718 for EZFluence (RADEZ V2), Substantially Equivalent on 2026-08-31. Applicant: Radformation, Inc.. Device class: 2.
Summary
Radformation's EZFluence (RADEZ V2) is filed under product code IYE, medical linear accelerators. The record gives no description of the product beyond its name and that code.
Class II, 21 CFR 892.5050. Radiology is both the classification panel and the review panel, and it was a Traditional 510(k).
Radformation filed from New York, New York. The decision came 97 calendar days after FDA received it (May 26 to August 31, 2026): substantially equivalent.
Clearance details
- Applicant
- Radformation, Inc.
- Product code
- Product code IYE
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New York, NY, US
Recent devices under product code IYE
view allMore clearances from Radformation, Inc.
view allAdverse events under product code IYE
product code IYE- Malfunction
- 455
- Other
- 3
- Total
- 458
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.