FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Digital Radiographic Imaging Acquisition Software - DR (RiasDR)
K Number: K251038
·
Decision Aug 6, 2025
Classifications
1
FEI Numbers
599
Registration Numbers
599
Same Product Code
2271
Applicant Total
1
Review Days
125
Basic Information
- Device Name
- Digital Radiographic Imaging Acquisition Software - DR (RiasDR)
- K Number
- K251038
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shen Zhen Cambridge-Hit Co., Ltd.
- Date Received
- April 3, 2025
- Decision Date
- August 6, 2025
- Product Code
- LLZ
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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