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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 K041166
Device Name SIEMENS ENHANCED IMAGING SYSTEM
Original Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
2501 north barrington rd.
hoffman estates,  IL  60195 7372
Original Contact frank pokrop
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
JAK  
Date Received05/04/2004
Decision Date 05/17/2004
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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