FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MIM-Ablation
K Number: K220256
·
Decision Oct 7, 2022
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
8
Applicant Total
22
Review Days
249
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Basic Information
- Device Name
- MIM-Ablation
- K Number
- K220256
- 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
- January 31, 2022
- Decision Date
- October 7, 2022
- Product Code
- QTZ
- 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 |
|---|---|---|---|
| QTZ | Radiological Image Processing Software For Ablation Therapy Planning And Evaluation | FDA class 2 | Radiology |
Similar 510(k) Clearances
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Other Clearances by Mim Software, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K223774 | Contour ProtégéAI | Apr 6, 2023 | Substantially Equivalent |
| K223800 | MIM Additional Tracers | Jan 17, 2023 | Substantially Equivalent |