K253185
- 510(k) number
- K253185
- Device name
- Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System
- Applicant
- Carestream Health NY · US
- Product code
- IZL — System, X-Ray, Mobile
- Decision date
- 2026-03-11
- Date received
- 2025-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K253185.pdf
Official FDA record: K253185
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.