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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
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