510(k) K253163
K253163 is an FDA 510(k) premarket notification submitted by Ever Fortune.Ai, Co., Ltd. for the device "EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)". The FDA issued a decision of Substantially Equivalent on April 22, 2026. The device falls under product code QAS (Radiological Computer-Assisted Triage And Notification Software), a Class II device regulated under 21 CFR 892.2080. Ever Fortune.Ai, Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 22, 2026
- Date Received
- September 26, 2025
- 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 .