510(k) · Radiology

MR 5300 and MR 7700 R11 MR Systems

by Philips Medical Systems Nederlands B.V.

MR 5300 and MR 7700 R11 MR Systems is an AI-enabled medical device from Philips Medical Systems Nederlands B.V. that the U.S. FDA cleared through 510(k) K223442 on December 23, 2022. Its lead review panel is Radiology and its primary product code is LNH (System, Nuclear Magnetic Resonance Imaging).

See also FDA-cleared AI radiology devices in 2022, all FDA AI clearances in 2022, top radiology AI devices.

Key facts

Submission numberK223442
Pathway510(k)
Date of final decision
Company (FDA list)Philips Medical Systems Nederlands B.V.
Lead review panelRadiology
Primary product codeLNH — System, Nuclear Magnetic Resonance Imaging
Applicant (openFDA)Philips Medical Systems Nederlands B.V.
Applicant locationBest, NL
Device classClass 2
Regulation number21 CFR 892.1000
Decision codeSESE
Submission typeSpecial

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. MR 5300 and MR 7700 R11 MR Systems went through this pathway (K223442).

openFDA lists it as a Class 2 device under 21 CFR 892.1000. Class II devices are moderate risk and are subject to general and special controls.

Product code LNH covers 100 devices on the FDA AI list. By decision date, this device is #39 of 100 under that code. Philips Medical Systems Nederlands B.V. 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.

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