Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MRCAT brain

K-Number: K193109 · 2020-01-24

Decision Date2020-01-24
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MRCAT brain is a medical device manufactured by Philips Medical Systems MR Finland. It received FDA 510(k) clearance on 2020-01-24 under approval 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. It is manufactured by Philips Medical Systems MR Finland. The 510(k) number is K193109.

When was MRCAT brain approved by the FDA?

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

What company makes MRCAT brain?

MRCAT brain is manufactured by Philips Medical Systems MR Finland.

What is the FDA product code for MRCAT brain?

The FDA product code for MRCAT brain is MUJ.

Other Devices by Philips Medical Systems MR Finland

Related Devices (Code: MUJ)

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.