Cleveland, OH, US · 14 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| QKB | Radiological Image Processing Software For Radiation Therapy | Class II | Radiology | 7 | 2026-03-27 |
| LLZ | System, Image Processing, Radiological | Class II | Radiology | 6 | 2025-12-11 |
| QTZ | Radiological Image Processing Software For Ablation Therapy Planning And Evaluation | Class II | Radiology | 1 | 2022-10-07 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-02-19 | Class II | Ongoing | Z-1267-2025 | MIM software; System, Image Processing, Radiological | — | In situations where two images with differing Fields of View (FOV) complete an image fusion, an incorrect, elevated Maximum Standardized Uptake Value (SUV) wi… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-03-27 | K253270 | Contour ProtégéAI+ | QKB | Class II | Radiology |
| 2025-12-11 | K251883 | MIM LesionID Pro | LLZ | Class II | Radiology |
| 2025-02-03 | K250035 | Contour ProtégéAI+ | QKB | Class II | Radiology |
| 2024-10-23 | K243012 | MIM Symphony HDR Fusion | LLZ | Class II | Radiology |
| 2024-05-20 | K233620 | MIM - Centiloid Scaling | LLZ | Class II | Radiology |
| 2024-05-13 | K232862 | MIM Monte Carlo Dosimetry | LLZ | Class II | Radiology |
| 2024-05-06 | K232514 | MIM Dose Analysis | LLZ | Class II | Radiology |
| 2023-11-08 | K231765 | Contour ProtégéAI | QKB | Class II | Radiology |
| 2023-04-06 | K223774 | Contour ProtégéAI | QKB | Class II | Radiology |
| 2023-01-17 | K223800 | MIM Additional Tracers | LLZ | Class II | Radiology |
| 2022-10-07 | K220256 | MIM-Ablation | QTZ | Class II | Radiology |
| 2022-02-03 | K213976 | Contour ProtégéAI | QKB | Class II | Radiology |
| 2021-10-20 | K210632 | Contour ProtegeAI | QKB | Class II | Radiology |
| 2020-07-02 | K193252 | Contour ProtegeAI | QKB | Class II | Radiology |