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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 K123599
Device Name INGENUITY DIGITAL PET/CT
Applicant
PHILIPS HEALTHCARE (CLEVELAND)
595 MINER RD.
CLEVELAND,  OH  44143
Applicant Contact MICHAEL S PRETO
Correspondent
PHILIPS HEALTHCARE (CLEVELAND)
595 MINER RD.
CLEVELAND,  OH  44143
Correspondent Contact MICHAEL S PRETO
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
JAK  
Date Received11/21/2012
Decision Date 07/12/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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