INGENUITY TF PET/MR


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

Correspodent Contact eduard toerek
Regulation Number 892.1200
Classification Product Code
OUO  
Date Received 11/26/2010
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