|
|
| Device |
radiological computer-assisted prioritization software for lesions |
| Regulation Description |
Radiological computer aided triage and notification software. |
| Definition |
Radiological computer-assisted prioritization software for lesions is an image processing device intended to aid in prioritization and triage of time sensitive patient detection and diagnosis based on the analysis of medical images acquired from radiological signal acquisition systems. The device identifies or prioritizes time sensitive imaging for review by prespecified clinical users based on software-based image analysis but does not provide information from the image analysis other than triage and notification. |
| Product Code | QFM |
| Regulation Number |
892.2080
|
|---|
| Device Class |
2
|
| Premarket Reviews |
|---|
| Manufacturer | Decision |
|---|
| AIDOC MEDICAL , LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
5
|
| ANNALISE-AI |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| ANNALISE-AI PTY , LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| AVICENNA.AI |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| AZMED |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| BERING, LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| DEEPHEALTH, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| ENVISIONIT DEEPAI, LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| EVER FORTUNE.AI, CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| ISCHEMAVIEW, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| LUNIT, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| MEDCOGNETICS, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| MILVUE |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| QUANTA COMPUTER, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| QURE.AI TECHNOLOGIES |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| RIVERAIN TECHNOLOGIES, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| SHANGHAI UNITED IMAGING INTELLIGENCE CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| VINBIGDATA JOINT STOCK COMPANY |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| VINBRAIN JOINT STOCK COMPANY |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| VIZ. AI, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| VUNO, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| ZEBRA MEDICAL VISION, LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|
