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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 K113276
Device Name CATALYST
Applicant
C-Rad Positioning AB
Bredgrand 18
Uppsala,  SE 75320
Applicant Contact JANINA OSTLING
Correspondent
C-Rad Positioning AB
Bredgrand 18
Uppsala,  SE 75320
Correspondent Contact JANINA OSTLING
Regulation Number892.5050
Classification Product Code
IYE  
Date Received11/07/2011
Decision Date 02/27/2012
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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