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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 K212230
Device Name TruSPECT Radiological Image Processing Station
Applicant
Spectrum Dynamics Medical Ltd
22 Bareket St
North Industrial Park
Caesarea,  IL 3079837
Applicant Contact Igor Naroditsky
Correspondent
Spectrum Dynamics Medical Ltd
22 Bareket St
North Industrial Park
Caesarea,  IL 3079837
Correspondent Contact Igor Naroditsky
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Code
QIH  
Date Received07/16/2021
Decision Date 08/16/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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