K231892
- 510(k) number
- K231892
- Device name
- Definium Pace Select
- Applicant
- Ge Hualun Medical Systems Co. , Ltd. CN
- Product code
- KPR — System, X-Ray, Stationary
- Decision date
- 2023-09-12
- Date received
- 2023-06-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K231892.pdf
Official FDA record: K231892
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.