Vereos PET/CT

System, Tomography, Computed, Emission

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 Vereos Pet/ct.

Pre-market Notification Details

Device IDK210880
510k NumberK210880
Device Name:Vereos PET/CT
ClassificationSystem, Tomography, Computed, Emission
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 CodeKPS  
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-24
Decision Date2021-05-19

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