|
|
| Device |
radiological computer-assisted triage and notification software |
| Regulation Description |
Radiological computer aided triage and notification software. |
| Definition |
Radiological computer-assisted triage and notification software 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 | QAS |
| Regulation Number |
892.2080
|
|---|
| Device Class |
2
|
| Premarket Reviews |
|---|
| Manufacturer | Decision |
|---|
| A2Z RADIOLOGY AI, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| AIDOC MEDICAL , LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
17
|
| ANNALISE-AI PTY , LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
4
|
| AVICENNA.AI |
| |
SUBSTANTIALLY EQUIVALENT
|
4
|
| BRAINOMIX LIMITED |
| |
SUBSTANTIALLY EQUIVALENT
|
4
|
| CIRCLE NEUROVASCULAR IMAGING, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| EVER FORTUNE.AI, CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
4
|
| HARRISON-AI MEDICAL PTY, LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| HEURON CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| INFERVISION MEDICAL TECHNOLOGY CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| ISCHEMAVIEW |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| ISCHEMAVIEW, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
6
|
| JLK, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
4
|
| METHINKS SOFTWARE, S.L |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| MLHEALTH 360 |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| NEUROCAREAI, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| NICOLAB B.V. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| QURE.AI TECHNOLOGIES |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| SHANGHAI UNITED IMAGING INTELLIGENCE CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| SIEMENS MEDICAL SOLUTIONS USA, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
3
|
| SK, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| VIZ. AI, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
3
|
|
|
|
|
