IQon Spectral CT

System, X-ray, Tomography, Computed

Philips Medical Systems, Nederland B.V.

The following data is part of a premarket notification filed by Philips Medical Systems, Nederland B.v. with the FDA for Iqon Spectral Ct.

Pre-market Notification Details

Device IDK193454
510k NumberK193454
Device Name:IQon Spectral CT
ClassificationSystem, X-ray, Tomography, Computed
Applicant Philips Medical Systems, Nederland B.V. Veenpluis 4-6 Best,  NL 5684 Pc
ContactNimit Shah
CorrespondentNimit Shah
Philips Medical Systems, Nederland B.V. Veenpluis 4-6 Best,  NL 5684 Pc
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelRadiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-13
Decision Date2020-01-24

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