K252911
- 510(k) number
- K252911
- Device name
- Lux HD 2530 detector (Lux HD 2530)
- Applicant
- Iray Imaging Technology (Haining) Limited CN
- Product code
- MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager)
- Decision date
- 2025-10-09
- Date received
- 2025-09-12
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K252911.pdf
Official FDA record: K252911
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.