Radiology · 510(k) · 2025
Definium Tempo Select
GE Hualun Medical Systems Co., Ltd. Cleared by FDA on 28 August 2025 under submission K250788, product code KPR (system, x-ray, stationary). What FDA's record says, in FDA's words.
Device record · K250788
- Device. Definium Tempo SelectDEVICE
- Company. GE Hualun Medical Systems Co., Ltd (CN)COMPANY
- Decision. 28 August 2025, 510(k), substantially equivalent (traditional review); received 14 March 2025DECISION
- Panel. RadiologyPANEL
- Product code. KPR, System, X-Ray, StationaryCODE
- Regulation. 21 CFR 892.1680, Class IIREG
- Source. FDA database entry · decision document (12 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The Definium Tempo Select is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts in patients of all ages. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position and the system is intended for use in all routine radiography exams. Optional image pasting function enables the operator to stitch sequentially acquired radiographs into a single image. The device is not intended for mammographic applications.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedradiographs (X-ray)
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 1,233 reports filed against devices carrying product code KPR. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
30 September 2026 · Other · SIEMENS MULTIX C · report MW6003180
A patient was not involved in the equipment incident. The technologist was preparing the room for x-ray. He walked up to the overhead lube and was getting ready to move it when the screen flash and went black. The tube then telescoped down about two-three feet and sprung back up to which the technologist heard the locking pin engage. Tech states that the power to the overhead seemed to cut out for a second, the lock released the tube as described, and once it sprung back up, it engaged. Upon […]
16 September 2026 · Malfunction · Radiography 7300 C · Philips Medical Systems DMC GmbH · report 3003768251-2026-100032
28 August 2026 · Malfunction · Radiography 7300 C · Philips Medical Systems DMC GmbH · report 3003768251-2026-100026
28 August 2026 · Malfunction · Radiography 7300 C · Philips Medical Systems DMC GmbH · report 3003768251-2026-100027
It was reported that the Ceiling Suspension (CS) was difficult to move in all directions, including longitudinal and transverse movement. The device was in clinical use and one radiographer reported experiencing muscle and joint strain, particularly in the right shoulder, which was associated with operation of the tube assembly.
28 August 2026 · Malfunction · Radiography 7300 C · Philips Medical Systems DMC GmbH · report 3003768251-2026-100028
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code KPR, in Radiology, from GE Hualun Medical Systems Co., Ltd, or cleared in 2025. The whole record is at FDA AI-enabled medical devices.
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