DS TorsoCardiac 1.5T, DS MSK S 1.5T, DS MSK M 1.5T

Coil, Magnetic Resonance, Specialty

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 Ds Torsocardiac 1.5t, Ds Msk S 1.5t, Ds Msk M 1.5t.

Pre-market Notification Details

Device IDK212864
510k NumberK212864
Device Name:DS TorsoCardiac 1.5T, DS MSK S 1.5T, DS MSK M 1.5T
ClassificationCoil, Magnetic Resonance, Specialty
Applicant Philips Healthcare (Suzhou) Co., Ltd No.258, ZhongYuan Road, Suzhou Industrial Park Suzhou,  CN 215024
ContactSeaman Shao
CorrespondentSeaman Shao
Philips Healthcare (Suzhou) Co., Ltd No.258, ZhongYuan Road, Suzhou Industrial Park Suzhou,  CN 215024
Product CodeMOS  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-08
Decision Date2021-12-01

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838096837 K212864 000
00884838096820 K212864 000
00884838096813 K212864 000

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