510(k) · Radiology

uMI Panorama

by Shanghai United Imaging Healthcare Co.,Ltd.

uMI Panorama is an AI-enabled medical device from Shanghai United Imaging Healthcare Co.,Ltd. that the U.S. FDA cleared through 510(k) K241585 on August 30, 2024. Its lead review panel is Radiology and its primary product code is KPS (System, Tomography, Computed, Emission).

See also FDA-cleared AI radiology devices in 2024, all FDA AI clearances in 2024, top radiology AI devices.

Key facts

Submission numberK241585
Pathway510(k)
Date of final decision
Company (FDA list)Shanghai United Imaging Healthcare Co.,Ltd.
Lead review panelRadiology
Primary product codeKPS — System, Tomography, Computed, Emission
Applicant (openFDA)Shanghai United Imaging Healthcare Co., Ltd.
Applicant locationShanghai, CN
Device classClass 2
Regulation number21 CFR 892.1200
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. uMI Panorama went through this pathway (K241585).

openFDA lists it as a Class 2 device under 21 CFR 892.1200. Class II devices are moderate risk and are subject to general and special controls.

Product code KPS covers 26 devices on the FDA AI list. By decision date, this device is #19 of 26 under that code. Shanghai United Imaging Healthcare Co.,Ltd. has 6 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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