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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Planning, Radiation Therapy Treatment
510(k) Number K220582
Device Name ClearCalc Model RADCA V2
Applicant
Radformation, Inc.
335 Madison Avenue, 4th floor
New York,  NY  10017
Applicant Contact Kurt Sysock
Correspondent
Radformation, Inc.
335 Madison Avenue, 4th floor
New York,  NY  10017
Correspondent Contact Kurt Sysock
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received03/01/2022
Decision Date 08/22/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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