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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 K233908
Device Name cNeuro cDAT
Applicant
Combinostics OY
Hatanpään Valtatie 24
Tampere,  FI 33100
Applicant Contact Lennart Thurfjell
Correspondent
RQM+
2790 Mosside Blvd. #800
Monroeville,  PA  15146
Correspondent Contact Erin Gontang
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/12/2023
Decision Date 07/01/2024
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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