Devices · GE Hualun Medical Systems Co., Ltd
Definium Tempo Select
GE Hualun Medical Systems Co., Ltd is listed for Definium Tempo Select (K250788). The FDA list gives August 28, 2025 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is KPR. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250788
- Date of final decision
- August 28, 2025
- Company on the FDA list
- GE Hualun Medical Systems Co., Ltd
- Lead panel
- Radiology
- Primary product code
- KPR
- openFDA device name for the code
- System, X-Ray, Stationary
- Device class
- 2
- Regulation number
- 892.1680
- openFDA decision description
- Substantially Equivalent
- openFDA decision code
- SESE
- Statement or summary label
- Summary