MRCAT Head & Neck— 510(k) K214081

Substantially Equivalent

Philips OY

FDA 510(k) clearance K214081 for MRCAT Head & Neck, Substantially Equivalent on 2022-04-05. Applicant: Philips OY. Device class: 2.

Clearance details

Applicant: Philips OY
Product code: Code MUJ
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2021-12-27
Decision date: 2022-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vantaa, FI

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.