ClearCheck Model RADCC V2— 510(k) K220583

Substantially Equivalent

Radformation, Inc.

FDA 510(k) clearance K220583 for ClearCheck Model RADCC V2, Substantially Equivalent on 2022-08-23. Applicant: Radformation, Inc..

Clearance details

Applicant: Radformation, Inc.
Product code: Code IYE
Advisory panel: Radiology
Date received: 2022-03-01
Decision date: 2022-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.