FDA 510(k) Premarket Notification K253962: ClearCheck (RADCC V2.7)

Submission Details & Decision

Normalized public record details for 510(k) notification K253962.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K253962

Applicant / Sponsor

Radformation, Inc.

Device Name

ClearCheck (RADCC V2.7)

Product Code

IYE

Decision Date

2026-04-03

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Radiology (RA)

Clearance Type

Traditional

Third Party Flag

Date Received

2025-12-11

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