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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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