Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T

K-Number: K212864 · 2021-12-01

ApplicantPhilips Healthcare (Suzhou) Co., Ltd.
Decision Date2021-12-01
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T is a medical device manufactured by Philips Healthcare (Suzhou) Co., Ltd.. It received FDA 510(k) clearance on 2021-12-01 under approval number K212864. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T?

dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T is a medical device that received FDA 510(k) clearance on 2021-12-01. It is manufactured by Philips Healthcare (Suzhou) Co., Ltd.. The 510(k) number is K212864.

When was dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T approved by the FDA?

dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T received FDA 510(k) clearance on 2021-12-01, under approval number K212864.

What company makes dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T?

dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T is manufactured by Philips Healthcare (Suzhou) Co., Ltd..

What is the FDA product code for dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T?

The FDA product code for dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T is MOS.

Other Devices by Philips Healthcare (Suzhou) Co., Ltd.

K163410DigitalDiagnost C50 K173507Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 K180015Philips Incisive CT K191136Access CT K201640DuraDiagnost K211168Philips Incisive CT on Trailer

View all 16 devices →

Related Devices (Code: MOS)

K16262316ch T/R Hand Wrist CoilQuality Electrodynamics, LLC K162966TxRx Knee 15 Flare MR Coil 1.5TQuality Electrodynamics, LLC K163066TxRx Knee 15 Flare MR Coil 3.0TQuality Electrodynamics, LLC K162863dS Small Extremity 16CH 1.5T CoilInvivo Therapeutics Corporation K16202916ch T/R Knee CoilQuality Electrodynamics, LLC K162079TRILLIUM Oval Head Coil 32Hitachi Medical Systems America, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑