510(k) · Radiology

uOmnispace.MI

by Shanghai United Imaging Healthcare Co., Ltd.

uOmnispace.MI is an AI-enabled medical device from Shanghai United Imaging Healthcare Co., Ltd. that the U.S. FDA cleared through 510(k) K233176 on December 20, 2023. Its lead review panel is Radiology and its primary product code is LLZ (System, Image Processing, Radiological).

See also FDA-cleared AI radiology devices in 2023, all FDA AI clearances in 2023, top radiology AI devices.

Key facts

Submission numberK233176
Pathway510(k)
Date of final decision
Company (FDA list)Shanghai United Imaging Healthcare Co., Ltd.
Lead review panelRadiology
Primary product codeLLZ — System, Image Processing, Radiological
Applicant (openFDA)Shanghai United Imaging Healthcare Co., Ltd.
Applicant locationShanghai, CN
Device classClass 2
Regulation number21 CFR 892.2050
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. uOmnispace.MI went through this pathway (K233176).

openFDA lists it as a Class 2 device under 21 CFR 892.2050. Class II devices are moderate risk and are subject to general and special controls.

Product code LLZ covers 161 devices on the FDA AI list. By decision date, this device is #139 of 161 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.

Similar devices (product code LLZ)

More from Shanghai United Imaging Healthcare Co., Ltd.