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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 K231570
Device Name StrokeViewer Perfusion
Applicant
Nico-Lab B.V.
Paascheuvelweg 25
Amsterdam,  NL 1105BP
Applicant Contact Veronica Padharia
Correspondent
Nico-Lab B.V.
Paascheuvelweg 25
Amsterdam,  NL 1105BP
Correspondent Contact Veronica Padharia
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/31/2023
Decision Date 12/14/2023
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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