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 IDK180015
510k NumberK180015
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
ContactGordon Shu
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 Received2018-01-02
Decision Date2018-03-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838085015 K180015 000
00884838105508 K180015 000

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