PHILIPS CT DYNAMIC MYOCARDIAL PERFUSION (DMP) APPLICATION

System, X-ray, Tomography, Computed

PHILIPS MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Philips Ct Dynamic Myocardial Perfusion (dmp) Application.

Pre-market Notification Details

Device IDK133603
510k NumberK133603
Device Name:PHILIPS CT DYNAMIC MYOCARDIAL PERFUSION (DMP) APPLICATION
ClassificationSystem, X-ray, Tomography, Computed
Applicant PHILIPS MEDICAL SYSTEMS 595 MINER ROAD Cleveland,  OH  44143
ContactSusan Quick
CorrespondentSusan Quick
PHILIPS MEDICAL SYSTEMS 595 MINER ROAD Cleveland,  OH  44143
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-11-25
Decision Date2014-09-25
Summary:summary

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