|
|
| Device |
radiological image processing software for radiation therapy |
| Regulation Description |
Medical image management and processing system. |
| 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
|
3
|
| GE HEALTHCARE |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| GE MEDICAL SYSTEMS, LLC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| LIMBUS AI, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| MANTEIA TECHNOLOGIES CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
3
|
| MEDMIND TECHNOLOGY CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| MIM SOFTWARE, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
5
|
| MVISION AI |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| MVISION AI OY |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| ONCOSOFT. CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| QUANTA COMPUTER, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| QUANTITATIVE RADIOLOGY SOLUTIONS, LLC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| RADFORMATION, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
3
|
| SIEMENS HEALTHCARE GMBH |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| SIEMENS MEDICAL SOLUTIONS U.S.A. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| SIEMENS MEDICAL SOLUTIONS USA, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| TAIWAN MEDICAL IMAGING CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| THERAPANACEA |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| THERAPANACEA SAS |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| VYSIONEER, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
3
|
| WISDOM TECHNOLOGIES., INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|
