EZFluence (RADEZ V2)
FDA 510(k) K261718 · Radformation, Inc.
510(k) numberK261718
Submission
- Device name
- EZFluence (RADEZ V2)
- Applicant
- Radformation, Inc.
New York, NY, US - Received
- May 26, 2026
- Decision date
- August 31, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was EZFluence (RADEZ V2) cleared by the FDA?
EZFluence (RADEZ V2) (K261718) received a 510(k) decision of Substantially Equivalent on August 31, 2026, 97 days after the submission was received.
What is the product code of K261718?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.