FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Contour ProtégéAI
K Number: K223774
·
Decision Apr 6, 2023
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
45
Applicant Total
22
Review Days
111
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Basic Information
- Device Name
- Contour ProtégéAI
- K Number
- K223774
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mim Software, Inc.
- Date Received
- December 16, 2022
- Decision Date
- April 6, 2023
- 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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Other Clearances by Mim Software, Inc.
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|---|---|---|---|
| K253270 | Contour ProtégéAI+ | Mar 27, 2026 | Substantially Equivalent |
| K251883 | MIM LesionID Pro | Dec 11, 2025 | Substantially Equivalent |
| K250035 | Contour ProtégéAI+ | Feb 3, 2025 | Substantially Equivalent |
| K243012 | MIM Symphony HDR Fusion | Oct 23, 2024 | Substantially Equivalent |
| K233620 | MIM - Centiloid Scaling | May 20, 2024 | Substantially Equivalent |
| K232862 | MIM Monte Carlo Dosimetry | May 13, 2024 | Substantially Equivalent |
| K232514 | MIM Dose Analysis | May 6, 2024 | Substantially Equivalent |
| K231765 | Contour ProtégéAI | Nov 8, 2023 | Substantially Equivalent |
| K223800 | MIM Additional Tracers | Jan 17, 2023 | Substantially Equivalent |
| K220256 | MIM-Ablation | Oct 7, 2022 | Substantially Equivalent |