Clearance Summary
DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector received FDA 510(k) clearance under submission number K250954, sponsored by Carestream Health. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2026-01-20.
- Submission: K250954
- Applicant / Sponsor: Carestream Health
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2026-01-20
Classification & Regulation
This clearance is catalogued under FDA product code KPR and 21 CFR 892.1680, within the Radiology review panel as a Class II device.