510(k) · Radiology

uMR 780

by Shanghai United Imaging Healthcare Co., Ltd

uMR 780 is an AI-enabled medical device from Shanghai United Imaging Healthcare Co., Ltd that the U.S. FDA cleared through 510(k) K193176 on May 5, 2020. 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 2020, all FDA AI clearances in 2020, top radiology AI devices.

Key facts

Submission numberK193176
Pathway510(k)
Date of final decision
Company (FDA list)Shanghai United Imaging Healthcare Co., Ltd
Lead review panelRadiology
Primary product codeLNH — System, Nuclear Magnetic Resonance Imaging
Applicant (openFDA)Shanghai United Imaging Healthcare Co., Ltd.
Applicant locationShanghai, CN
Device classClass 2
Regulation number21 CFR 892.1000
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. uMR 780 went through this pathway (K193176).

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 #8 of 100 under that code. Shanghai United Imaging Healthcare Co., Ltd has 33 AI-enabled devices 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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