FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
Advanced Algorithms for Treatment Management Applications (AATMA)
K Number: K212218
·
Decision Oct 25, 2021
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
45
Applicant Total
14
Review Days
101
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Basic Information
- Device Name
- Advanced Algorithms for Treatment Management Applications (AATMA)
- K Number
- K212218
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Elekta Solutions AB
- Date Received
- July 16, 2021
- Decision Date
- October 25, 2021
- 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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