K243556 is an FDA 510(k) clearance for the Lux HD 35 Detector (Lux HD 35). This device is classified as a Solid State X-ray Imager (flat Panel/digital Imager) (Class II - Special Controls, product code MQB).
Submitted by Iray Imaging Technology (Haining) Limited (Haining, CN). The FDA issued a Cleared decision on March 18, 2025, 120 days after receiving the submission on November 18, 2024.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K243556 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 18, 2024 |
| Decision Date | March 18, 2025 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MQB - Solid State X-ray Imager (flat Panel/digital Imager) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1680 |