PHILIPS IQON SPECTRAL CT

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 Philips Iqon Spectral Ct.

Pre-market Notification Details

Device IDK133674
510k NumberK133674
Device Name:PHILIPS IQON SPECTRAL CT
ClassificationSystem, X-ray, Tomography, Computed
Applicant PHILIPS HEALTHCARE (CLEVELAND) 595 MINER RD. Cleveland,  OH  44143
ContactCatherine M Connell
CorrespondentCatherine M Connell
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 Received2013-11-29
Decision Date2014-11-21
Summary:summary

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