510(k) K211179
K211179 is an FDA 510(k) premarket notification submitted by Infervision Medical Technology Co., Ltd. for the device "InferRead CT Stroke.AI". The FDA issued a decision of Substantially Equivalent on August 12, 2021. The device falls under product code QAS (Radiological Computer-Assisted Triage And Notification Software), a Class II device regulated under 21 CFR 892.2080. Infervision Medical Technology Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 12, 2021
- Date Received
- April 20, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radiological Computer-Assisted Triage And Notification Software
- Device Class
- Class II
- Regulation Number
- 892.2080
- Review Panel
- RA
- Submission Type
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 .