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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K203195
Device Name Simpleware ScanIP Medical
Applicant
Synopsys (Northern Europe) , Ltd.
Bradninch Hall, Castle St.
Exeter,  GB EX4 3PL
Applicant Contact Jessica James
Correspondent
Synopsys (Northern Europe) , Ltd.
Bradninch Hall, Castle St.
Exeter,  GB EX4 3PL
Correspondent Contact Jessica James
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/28/2020
Decision Date 04/01/2021
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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