ClearCheck Model RADCC V2

FDA 510(k) K220583 · Radformation, Inc.

Substantially Equivalent

510(k) numberK220583

Submission

Device name
ClearCheck Model RADCC V2
Applicant
Radformation, Inc.
New York, NY, US
Received
March 1, 2022
Decision date
August 23, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IYE – Accelerator, Linear, Medical
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5050
Specialty
Radiology

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Questions and answers

When was ClearCheck Model RADCC V2 cleared by the FDA?

ClearCheck Model RADCC V2 (K220583) received a 510(k) decision of Substantially Equivalent on August 23, 2022, 175 days after the submission was received.

What is the product code of K220583?

The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.