IMR SOFTWARE APPLICATION

System, X-ray, Tomography, Computed

PHILIPS HEALTHCARE (CLEVELAND)

The following data is part of a premarket notification filed by Philips Healthcare (cleveland) with the FDA for Imr Software Application.

Pre-market Notification Details

Device IDK123576
510k NumberK123576
Device Name:IMR SOFTWARE APPLICATION
ClassificationSystem, X-ray, Tomography, Computed
Applicant PHILIPS HEALTHCARE (CLEVELAND) 595 MINER RD. Cleveland,  OH  44143
ContactChristine Anderson
CorrespondentChristine Anderson
PHILIPS HEALTHCARE (CLEVELAND) 595 MINER RD. Cleveland,  OH  44143
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-11-20
Decision Date2013-06-07
Summary:summary

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