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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tomographic imager combining emission computed tomography with nuclear magnetic resonance
510(k) Number K103483
Device Name INGENUITY TF PET/MR
Applicant
PHILIPS HEALTHCARE (CLEVELAND)
595 MINER RD.
CLEVELAND,  OH  44143
Applicant Contact EDUARD TOEREK
Correspondent
PHILIPS HEALTHCARE (CLEVELAND)
595 MINER RD.
CLEVELAND,  OH  44143
Correspondent Contact EDUARD TOEREK
Regulation Number892.1200
Classification Product Code
OUO  
Date Received11/26/2010
Decision Date 11/23/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Recalls CDRH Recalls
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