FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Lux HD 2530 detector (Lux HD 2530)
K Number: K252911
·
Decision Oct 9, 2025
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
422
Applicant Total
4
Review Days
27
Basic Information
- Device Name
- Lux HD 2530 detector (Lux HD 2530)
- K Number
- K252911
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Iray Imaging Technology (Haining) Limited
- Date Received
- September 12, 2025
- Decision Date
- October 9, 2025
- Product Code
- MQB
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | FDA class 2 | Radiology |
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