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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 K231047
Device Name UniSyn Molecular Imaging (6-3-1)
Applicant
Convergent Imaging Solutions
36 Rideau River Lane
Ottawa,  CA K1S 0X1
Applicant Contact Mathew Thomas
Correspondent
Convergent Imaging Solutions
36 Rideau River Lane
Ottawa,  CA K1S 0X1
Correspondent Contact Mathew Thomas
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Code
IYX  
Date Received04/12/2023
Decision Date 09/01/2023
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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