Precise Position

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 Precise Position.

Pre-market Notification Details

Device IDK203514
510k NumberK203514
Device Name:Precise Position
ClassificationSystem, X-ray, Tomography, Computed
Applicant Philips Healthcare (Suzhou) Co., Ltd. No. 258, Zhong Yuan, Suzhou Industrial Park Suzhou,  CN 215024
ContactShiguang An
CorrespondentShiguang An
Philips Healthcare (Suzhou) Co., Ltd. No. 258, Zhong Yuan, Suzhou Industrial Park Suzhou,  CN 215024
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-30
Decision Date2021-06-17

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