510(k) · Radiology

MRCAT brain

by Philips Medical Systems MR Finland

MRCAT brain is an AI-enabled medical device from Philips Medical Systems MR Finland that the U.S. FDA cleared through 510(k) K193109 on January 24, 2020. Its lead review panel is Radiology and its primary product code is MUJ (System, Planning, Radiation Therapy Treatment).

See also FDA-cleared AI radiology devices in 2020, all FDA AI clearances in 2020, top radiology AI devices.

Key facts

Submission numberK193109
Pathway510(k)
Date of final decision
Company (FDA list)Philips Medical Systems MR Finland
Lead review panelRadiology
Primary product codeMUJ — System, Planning, Radiation Therapy Treatment
Applicant (openFDA)Philips Medical Systems MR Finland
Applicant locationVantaa, FI
Device classClass 2
Regulation number21 CFR 892.5050
Decision codeSESE
Submission typeTraditional

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. MRCAT brain went through this pathway (K193109).

openFDA lists it as a Class 2 device under 21 CFR 892.5050. Class II devices are moderate risk and are subject to general and special controls.

Product code MUJ covers 33 devices on the FDA AI list. By decision date, this device is #4 of 33 under that code. Philips Medical Systems MR Finland has 1 AI-enabled device on the list, and the Radiology panel accounts for 1,230 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

Similar devices (product code MUJ)