Cleared Traditional

ChartCheck (RADCH V1.6)

K252988 · Radformation, Inc. · Radiology
Jan 2026
Decision
109d
Days
Class 2
Risk

About This 510(k) Submission

K252988 is an FDA 510(k) clearance for the ChartCheck (RADCH V1.6), a Accelerator, Linear, Medical (Class II — Special Controls, product code IYE), submitted by Radformation, Inc. (New York, US). The FDA issued a Cleared decision on January 5, 2026, 109 days after receiving the submission on September 18, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K252988 FDA.gov
FDA Decision Cleared SESE
Date Received September 18, 2025
Decision Date January 05, 2026
Days to Decision 109 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IYE — Accelerator, Linear, Medical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5050

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