Philips Incisive CT

System, X-ray, Tomography, Computed

Philips Healthcare (Suzhou) Co., Ltd.

The following data is part of a premarket notification filed by Philips Healthcare (suzhou) Co., Ltd. with the FDA for Philips Incisive Ct.

Pre-market Notification Details

Device IDK212441
510k NumberK212441
Device Name:Philips Incisive CT
ClassificationSystem, X-ray, Tomography, Computed
Applicant Philips Healthcare (Suzhou) Co., Ltd. No. 258, Zhongyuan Road, Suzhou Industrial Park Suzhou,  CN 215024
ContactShiguang An
CorrespondentShiguang An
Philips Healthcare (Suzhou) Co., Ltd. No. 258, Zhongyuan Road, Suzhou Industrial Park Suzhou,  CN 215024
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-04
Decision Date2022-04-27

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