FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
DeepBT Detector-Plus
K Number: K252190
·
Decision Apr 10, 2026
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
45
Applicant Total
1
Review Days
270
Basic Information
- Device Name
- DeepBT Detector-Plus
- K Number
- K252190
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aitewan Biomedical Technology, Inc.
- Date Received
- July 14, 2025
- Decision Date
- April 10, 2026
- Product Code
- QKB
- 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 |
|---|---|---|---|
| QKB | Radiological Image Processing Software For Radiation Therapy | FDA class 2 | Radiology |
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