ContourProtégéAI
3 catalogue numbers from 1.2, listed by MIM Software Inc., United States, under Radiological Image Processing Software For Radiation Therapy. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
3catalogue numbers in this listing
7510(k) clearances naming this product code
Who Else Makes It
Concentrated in Fujian (1), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Manteia Technologies Co., Ltd. | Xiamen | Fujian | Manufacturer | 3 |
| Medmind Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 1 |
Record
| Listed by | MIM Software Inc., United States |
|---|---|
| FDA product code | QKB |
| Device type | Radiological Image Processing Software For Radiation Therapy |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2050 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K223774 |
| Record published | 2023-08-20 |
| Record revised | 2023-10-18 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1.2 | In distribution | |
| 1.4 | In distribution | |
| 1.3 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| AI-Rad Companion Organs RT | Siemens Healthcare Limited | 6 |
| AccuContour | Manteia Technologies Co., Ltd. | 4 |
| ART-Plan | Therapanacea | 3 |
| AutoContour | Radformation, Inc. | 2 |
| DeepContour | Wisdom Medical Technologies | 1 |
| ContourProtégéAI – CT Abdomen | MIM Software Inc. | 1 |
| VBrain | Vysioneer, Inc. | 1 |
| ContourProtégéAI – MR Prostate | MIM Software Inc. | 1 |
| RT-Mind-AI | Medmind Technology Co., Ltd. | 1 |
| MRI Planner | Spectronic Medical AB | 1 |
| ContourProtégéAI – CT Prostate | MIM Software Inc. | 1 |
| Aview RT ACS | Coreline Soft Co., Ltd. | 1 |
Showing 12 of 25. All products under Radiological Image Processing Software For Radiation Therapy
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253270 | 2026-03-27 |
| K250035 | 2025-02-03 |
| K231765 | 2023-11-08 |
| K223774 | 2023-04-06 |
| K213976 | 2022-02-03 |
| K210632 | 2021-10-20 |
| K193252 | 2020-07-02 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.