K242019
- 510(k) number
- K242019
- Device name
- GXR-Series Diagnostic X-Ray System
- Applicant
- DRGEM Corporation KR
- Product code
- KPR — System, X-Ray, Stationary
- Decision date
- 2025-01-07
- Date received
- 2024-07-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K242019.pdf
Official FDA record: K242019
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.