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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 K201933
Device Name ImagenSPECT 3.0
Applicant
Cardiovascular Imaging Technologies
4320 Wornall Rd., Suite 114
Kansas City,  MO  64111
Applicant Contact James A. Case
Correspondent
Pra Health Sciences
9755 Ridge Dr.
Lenexa,  KS  66219
Correspondent Contact Melanie Hasek
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
LLZ  
Date Received07/13/2020
Decision Date 08/11/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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