Cleared Traditional

K263109 - EFAI NEUROSUITE CTA LVO ASSESSMENT SYSTEM (LVO-CTA-100)

K263109 is an FDA 510(k) clearance for EFAI NEUROSUITE CTA LVO ASSESSMENT SYST..., manufactured by Ever Fortune.Ai, Co., Ltd.. The device is a Class 2 Radiology device with product code QAS cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K263109 · Ever Fortune.Ai, Co., Ltd. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
56d
Days
Class 2
Risk

K263109 is an FDA 510(k) clearance for the EFAI NEUROSUITE CTA LVO ASSESSMENT SYSTEM (LVO-CTA-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 October 30, 2026 after a review of 56 days - a notably fast clearance 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 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.

FDA 510(k) Submission Details - K263109

510(k) Number K263109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2026
Decision Date October 30, 2026
Days to Decision 56 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
51d faster than avg
Panel avg: 107d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QAS Device Classification - Class 2, Special Controls

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 89
Devices cleared under the same product code (QAS) and FDA review panel - the closest regulatory comparables to K263109.
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EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)
K253163 · Ever Fortune.Ai, Co., Ltd. · Apr 2026
K263109 · EFAI NEUROSUITE CTA LVO ASSESSMENT SYSTEM (LVO-CTA-100)
Download PDF FDA Summary Ever Fortune.Ai, Co.,…