ClearCheck (RADCC V2.7)— 510(k) K253962
Substantially EquivalentRadformation, Inc.
FDA 510(k) clearance K253962 for ClearCheck (RADCC V2.7), Substantially Equivalent on 2026-04-03. Applicant: Radformation, Inc.. Device class: 2.
Summary
Radformation's ClearCheck (RADCC V2.7) is filed under product code IYE (Accelerator, Linear, Medical). The name carries a version designation, V2.7.
Class II, 21 CFR 892.5050. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Radformation filed from New York, New York. The decision came 113 calendar days after FDA received it (December 11, 2025 to April 3, 2026).
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.