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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K231576
Device Name cNeuro cPET
Applicant
Combinostics OY
Hatanpään Valtatie 24
Tampere,  FI 33100
Applicant Contact Thurfjell Lennart
Correspondent
RQM+
2251 San Diego Ave. B-257
San Diego,  CA  92110
Correspondent Contact Erin Gontang
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
LLZ  
Date Received05/31/2023
Decision Date 09/14/2023
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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