K242678
- 510(k) number
- K242678
- Device name
- Definium Pace Select ET
- Applicant
- Ge Hualun Medical Systems Co. , Ltd. CN
- Product code
- KPR — System, X-Ray, Stationary
- Decision date
- 2024-10-01
- Date received
- 2024-09-06
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K242678.pdf
Official FDA record: K242678
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.