Radiology
InferRead CT Stroke.AI
Infervision Medical Technology Co., Ltd.
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 .
FDA Submission Metadata
- Submission number
- K211179
- Decision date
- August 2021
- FDA panel
- Radiology
- Product code
- QAS
- Clinical task (npj)
- triage
- Data modality (npj)
- Images
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
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