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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 K171350
Device Name Collision Check
Applicant
Radformation, Inc.
335 Madison Ave., 16th Floor
New York,  NY  10017
Applicant Contact Kurt Sysock
Correspondent
Radformation, Inc.
335 Madison Ave., 16th Floor
New York,  NY  10017
Correspondent Contact Kurt Sysock
Regulation Number892.5050
Classification Product Code
IYE  
Date Received05/09/2017
Decision Date 11/29/2017
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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