Cleared Traditional

K253163 - EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100) (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K253163 · Ever Fortune.Ai, Co., Ltd. · Radiology device
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Apr 2026
Decision
208d
Days
Class 2
Risk

K253163 is an FDA 510(k) clearance for the EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100). Classified as Radiological Computer-assisted Triage And Notification Software (product code QAS), Class II - Special Controls.

Submitted by Ever Fortune.Ai, Co., Ltd. (Taichung City, TW). The FDA issued a Cleared decision on April 22, 2026 after a review of 208 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2080 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Incremental AI imaging tool. Moderate-to-high equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Ever Fortune.Ai, Co., Ltd. devices

Submission Details

510(k) Number K253163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2025
Decision Date April 22, 2026
Days to Decision 208 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 107d · This submission: 208d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QAS Radiological Computer-assisted Triage And Notification Software
Device Class Class 2 - 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 .
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - QAS Radiological Computer-assisted Triage And Notification Software

All 83
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