510(k) · Radiology

Definium Tempo Select

by GE Hualun Medical Systems Co., Ltd

Definium Tempo Select is an AI-enabled medical device from GE Hualun Medical Systems Co., Ltd that the U.S. FDA cleared through 510(k) K250788 on August 28, 2025. Its lead review panel is Radiology and its primary product code is KPR (System, X-Ray, Stationary).

See also FDA-cleared AI radiology devices in 2025, all FDA AI clearances in 2025, top radiology AI devices.

Key facts

Submission numberK250788
Pathway510(k)
Date of final decision
Company (FDA list)GE Hualun Medical Systems Co., Ltd
Lead review panelRadiology
Primary product codeKPR — System, X-Ray, Stationary
Applicant (openFDA)Ge Hualun Medical Systems Co. , Ltd.
Applicant locationBeijing, CN
Device classClass 2
Regulation number21 CFR 892.1680
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. Definium Tempo Select went through this pathway (K250788).

openFDA lists it as a Class 2 device under 21 CFR 892.1680. Class II devices are moderate risk and are subject to general and special controls.

Product code KPR covers 6 devices on the FDA AI list. By decision date, this device is #5 of 6 under that code. GE Hualun Medical Systems Co., Ltd has 2 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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