Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)— 510(k) K243556
Substantially EquivalentIray Imaging Technology (Haining) Limited
FDA 510(k) clearance K243556 for Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43), Substantially Equivalent on 2025-03-18. Applicant: Iray Imaging Technology (Haining) Limited.
Clearance details
- Applicant
- Iray Imaging Technology (Haining) Limited
- Product code
- Code MQB
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Haining, CN
Data sourced from openFDA. This site is unofficial and independent of the FDA.