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 a medical device manufactured by Philips OY. It received FDA 510(k) clearance on 2022-04-05 under approval 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. It is manufactured by Philips OY. The 510(k) number is K214081.

When was MRCAT Head & Neck approved by the FDA?

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

What company makes MRCAT Head & Neck?

MRCAT Head & Neck is manufactured by Philips OY.

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

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

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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.