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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 K120668
Device Name SENTINEL
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 Received03/05/2012
Decision Date 07/30/2012
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
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