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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 K051170
Device Name GEMINI GXL
Original Applicant
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
595 miner rd.
cleveland,  OH  44143
Original Contact rae ann farrow
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
JAK  
Date Received05/06/2005
Decision Date 05/23/2005
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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