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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 K940236
Device Name QUANTITATIVE HEART
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
ROENTGEN ANGIOGRAPHY CHICAGO
2501 N. BARRINGTON ROAD
HOFFMAN ESTATES,  IL  60195 -7372
Applicant Contact IRENA KRUTULIS
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
ROENTGEN ANGIOGRAPHY CHICAGO
2501 N. BARRINGTON ROAD
HOFFMAN ESTATES,  IL  60195 -7372
Correspondent Contact IRENA KRUTULIS
Regulation Number892.1200
Classification Product Code
KPS  
Date Received01/18/1994
Decision Date 05/03/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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