K242821 is an FDA 510(k) clearance for the EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100). This device is classified as a Radiological Computer-assisted Triage And Notification Software (Class II — Special Controls, product code QAS).
Submitted by Ever Fortune.Ai, Co., Ltd. (Taichung City, TW). The FDA issued a Cleared decision on February 20, 2025, 155 days after receiving the submission on September 18, 2024.
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 | K242821 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 18, 2024 |
| Decision Date | February 20, 2025 |
| Days to Decision | 155 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 . |