K250954
- 510(k) number
- K250954
- Device name
- DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector
- Applicant
- Carestream Health NY · US
- Product code
- KPR — System, X-Ray, Stationary
- Decision date
- 2026-01-20
- Date received
- 2025-03-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K250954.pdf
Official FDA record: K250954
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.