K232178
- 510(k) number
- K232178
- Device name
- GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)
- Applicant
- DRGEM Corporation KR
- Product code
- KPR — System, X-Ray, Stationary
- Decision date
- 2023-09-19
- Date received
- 2023-07-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K232178.pdf
Official FDA record: K232178
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.