K243556
- 510(k) number
- K243556
- Device name
- Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)
- Applicant
- Iray Imaging Technology (Haining) Limited CN
- Product code
- MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager)
- Decision date
- 2025-03-18
- Date received
- 2024-11-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K243556.pdf
Official FDA record: K243556
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.