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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 K200435
Device Name Catalyst+, Catalyst+ HD
Applicant
C-Rad Positioning AB
Bredgränd 18
Uppsala,  SE 75320
Applicant Contact Thomas Matzen
Correspondent
C-Rad Positioning AB
Bredgränd 18
Uppsala,  SE 75320
Correspondent Contact Thomas Matzen
Regulation Number892.5050
Classification Product Code
IYE  
Date Received02/24/2020
Decision Date 05/07/2020
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
Recalls CDRH Recalls
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