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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 K172406
Device Name Ingenuity TF
Applicant
Philips Medical Systems (Cleveland) Inc.
595 Miner Rd
Cleveland,  OH  44143
Applicant Contact Christine Anderson
Correspondent
Philips Medical Systems (Cleveland) Inc.
595 Miner Rd
Cleveland,  OH  44143
Correspondent Contact Christine Anderson
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
JAK  
Date Received08/09/2017
Decision Date 10/06/2017
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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