FDA 510(k)

ds Head 32ch 3.0T

K-Number: K213351 · 2021-10-29

ApplicantInvivo Corporation (Business Trade Name: Philips)

Decision Date2021-10-29

Product CodeMOS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ds Head 32ch 3.0T is the device name listed in this FDA 510(k) record. The listed applicant is Invivo Corporation (Business Trade Name: Philips). It received FDA 510(k) clearance on 2021-10-29 under 510(k) number K213351. 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 Head 32ch 3.0T?

ds Head 32ch 3.0T is a medical device that received FDA 510(k) clearance on 2021-10-29. The listed applicant is Invivo Corporation (Business Trade Name: Philips). The 510(k) number is K213351.

When did ds Head 32ch 3.0T receive FDA 510(k) clearance?

ds Head 32ch 3.0T received FDA 510(k) clearance on 2021-10-29, under 510(k) number K213351.

Who is the listed applicant for ds Head 32ch 3.0T?

The FDA 510(k) record lists Invivo Corporation (Business Trade Name: Philips) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ds Head 32ch 3.0T?

The FDA product code for ds Head 32ch 3.0T is MOS.

Other records listing Invivo Corporation (Business Trade Name: Philips) as applicant

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

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