FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
ARTAssistant
K Number: K250780
·
Decision Dec 5, 2025
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
45
Applicant Total
6
Review Days
266
Basic Information
- Device Name
- ARTAssistant
- K Number
- K250780
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Manteia Technologies Co., Ltd.
- Date Received
- March 14, 2025
- Decision Date
- December 5, 2025
- 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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|---|---|---|---|
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