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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 K183606
Device Name Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)
Applicant
Scandidos AB
Dag Hammarskjölds Väg 52a
Uppsala,  SE 752 37
Applicant Contact Thomas Matzen
Correspondent
Scandidos AB
Dag Hammarskjölds Väg 52a
Uppsala,  SE 752 37
Correspondent Contact Thomas Matzen
Regulation Number892.5050
Classification Product Code
IYE  
Date Received12/26/2018
Decision Date 04/08/2019
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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