FDA 510(k)

MRCAT

K-Number: K151435 · 2016-02-25

ApplicantPhilips Medical Systems MR Finland

Decision Date2016-02-25

Product CodeMUJ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MRCAT is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems MR Finland. It received FDA 510(k) clearance on 2016-02-25 under 510(k) number K151435. 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?

MRCAT is a medical device that received FDA 510(k) clearance on 2016-02-25. The listed applicant is Philips Medical Systems MR Finland. The 510(k) number is K151435.

When did MRCAT receive FDA 510(k) clearance?

MRCAT received FDA 510(k) clearance on 2016-02-25, under 510(k) number K151435.

Who is the listed applicant for MRCAT?

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

What is the FDA product code for MRCAT?

The FDA product code for MRCAT is MUJ.

Other records listing Philips Medical Systems MR Finland 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.

K193109MRCAT brain K182888MRCAT Pelvis

Related Devices (Code: MUJ)

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.