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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 K202793
Device Name Cercare Medical Neurosuite
Applicant
Cercare Medical Aps
10 Inge Lehmanns Gade
Aarhus,  DK DK-8000
Applicant Contact Mikkel Bo Hansen
Correspondent
JW Regulatory Consulting, LLC
406 Wacouta St., Suite 417
Saint Paul,  MN  55101
Correspondent Contact Jennifer Willner
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/22/2020
Decision Date 05/17/2021
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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