FDA 510(k)

MRCAT Head & Neck

K-Number: K214081 · 2022-04-05

Decision Date2022-04-05

Product CodeMUJ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MRCAT Head & Neck is the device name listed in this FDA 510(k) record. The listed applicant is Philips OY. It received FDA 510(k) clearance on 2022-04-05 under 510(k) number K214081. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MRCAT Head & Neck?

MRCAT Head & Neck is a medical device that received FDA 510(k) clearance on 2022-04-05. The listed applicant is Philips OY. The 510(k) number is K214081.

When did MRCAT Head & Neck receive FDA 510(k) clearance?

MRCAT Head & Neck received FDA 510(k) clearance on 2022-04-05, under 510(k) number K214081.

Who is the listed applicant for MRCAT Head & Neck?

The FDA 510(k) record lists Philips OY as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MRCAT Head & Neck?

The FDA product code for MRCAT Head & Neck is MUJ.

Related Devices (Code: MUJ)

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.

K260750Virtual Cone (1.0)Varian Medical Systems, Inc.K253050RadOncAIInformai K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.K252784eXaSkin PlusAnatomical Geometry S.L.K253078ART.1-USSeetreat Pty, Ltd.K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.

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.