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 Spectral Ct.

Pre-market Notification Details

Device IDK203020
510k NumberK203020
Device Name:Spectral CT
ClassificationSystem, X-ray, Tomography, Computed
Applicant Philips Medical Systems Nederland B.V. Veenpluis 4-6 Best,  NL 5684 Pc
ContactYaara Oltchik
CorrespondentYaara Oltchik
Philips Medical Systems Nederland B.V. Veenpluis 4-6 Best,  NL 5684 Pc
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-02
Decision Date2021-02-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838101111 K203020 000

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