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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K252988
Device Name ChartCheck (RADCH V1.6)
Applicant
Radformation, Inc.
261 Madison Ave., 9th Floor
New York,  NY  10016
Applicant Contact Jennifer Wampler
Correspondent
Radformation, Inc.
261 Madison Ave., 9th Floor
New York,  NY  10016
Correspondent Contact Jennifer Wampler
Regulation Number892.5050
Classification Product Code
IYE  
Date Received09/18/2025
Decision Date 01/05/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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