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|
| Device |
radiological image processing software for radiation therapy |
| Definition |
To provide semi-automatic or fully-automated radiological image processing and analysis tools for radiation therapy. Software implementing artificial intelligence (AI) including nonadaptive machine learning algorithms trained with clinical and/or artificial radiological images. In these devices, the algorithm training images typically impact device performance. AI based radiological image processing software is intended to be used in the workflow of radiation therapy. Adaptive AI algorithms are not within the scope of this product code. Primary radiation dose calculation or plan optimization for treatment planning are not within scope of this product code. |
| Product Code | QKB |
| Regulation Number |
892.2050
|
|---|
| Device Class |
2
|
| Premarket Reviews |
|---|
| Manufacturer | Decision |
|---|
| CORELINE SOFT CO.,LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| DEEPVOXEL INC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| ELEKTA SOLUTIONS AB |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| EVER FORTUNE.AI CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| GE MEDICAL SYSTEMS, LLC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| MANTEIA TECHNOLOGIES CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| MEDMIND TECHNOLOGY CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| MIM SOFTWARE INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
5
|
| MVISION AI |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| QUANTA COMPUTER INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| QUANTITATIVE RADIOLOGY SOLUTIONS, LLC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| RADFORMATION, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
3
|
| SIEMENS MEDICAL SOLUTIONS U.S.A. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| SIEMENS MEDICAL SOLUTIONS USA, INC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| SIEMENS MEDICAL SOLUTIONS USA, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| THERAPANACEA |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| THERAPANACEA SAS |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| VYSIONEER INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
3
|
| WISDOM TECHNOLOGIES., INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| XIAMEN MANTEIA TECHNOLOGY LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
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