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FDA 510(k)

MRCAT brain

K-Number: K193109 · 2020-01-24

ApplicantPhilips Medical Systems MR Finland
Decision Date2020-01-24
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MRCAT brain 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 2020-01-24 under 510(k) number K193109. 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 brain?

MRCAT brain is a medical device that received FDA 510(k) clearance on 2020-01-24. The listed applicant is Philips Medical Systems MR Finland. The 510(k) number is K193109.

When did MRCAT brain receive FDA 510(k) clearance?

MRCAT brain received FDA 510(k) clearance on 2020-01-24, under 510(k) number K193109.

Who is the listed applicant for MRCAT brain?

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 brain?

The FDA product code for MRCAT brain 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.

K182888MRCAT PelvisK151435MRCAT

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.K253050RadOncAIInformaiK260207Multimodality 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

View on FDA Database →

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

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