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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 K122241
Device Name IMAGEN3D
Applicant
Cardiovascular Imaging Technologies
9755 Ridge Dr.
Lenexa,  KS  66219
Applicant Contact MELANIE HASEK
Correspondent
Cardiovascular Imaging Technologies
9755 Ridge Dr.
Lenexa,  KS  66219
Correspondent Contact MELANIE HASEK
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
LLZ  
Date Received07/27/2012
Decision Date 10/24/2012
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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