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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 K151426
Device Name ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+
Applicant
Scandidos AB
Dag Hammarskjolds Vag 52a
Uppsala,  SE SE-75237
Applicant Contact THOMAS MATZEN
Correspondent
Scandidos AB
Dag Hammarskjolds Vag 52a
Uppsala,  SE SE-75237
Correspondent Contact THOMAS MATZEN
Regulation Number892.5050
Classification Product Code
IYE  
Date Received05/28/2015
Decision Date 01/29/2016
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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