K211179 is an FDA 510(k) clearance for the InferRead CT Stroke.AI. This device is classified as a Radiological Computer-assisted Triage And Notification Software (Class II - Special Controls, product code QAS).
Submitted by Infervision Medical Technology Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on August 12, 2021, 114 days after receiving the submission on April 20, 2021.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2080. 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 ..
| 510(k) Number | K211179 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 20, 2021 |
| Decision Date | August 12, 2021 |
| Days to Decision | 114 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | QAS — Radiological Computer-assisted Triage And Notification Software |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2080 |
| 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 . |