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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 the device name listed in this FDA 510(k) record. The listed applicant is Philips Healthcare (Suzhou) Co., Ltd.. It received FDA 510(k) clearance on 2021-12-01 under 510(k) 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. The listed applicant is Philips Healthcare (Suzhou) Co., Ltd.. The 510(k) number is K212864.

When did dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T receive FDA 510(k) clearance?

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

Who is the listed applicant for dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T?

The FDA 510(k) record lists Philips Healthcare (Suzhou) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Philips Healthcare (Suzhou) Co., Ltd. as applicant

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Related Devices (Code: MOS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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