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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 K152503
Device Name ImagenSPECT
Applicant
Cardiovascular Imaging Technologies
4320 Wornall Rd., Suite 114
Kansas City,  MO  64111
Applicant Contact JAMES 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 Received09/02/2015
Decision Date 01/25/2016
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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