Cleared Traditional

K220264 - EFAI RTSuite CT HN-Segmentation System (FDA 510(k) Clearance)

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

K220264 · Ever Fortune.Ai, Co., Ltd. · Radiology device
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Apr 2022
Decision
87d
Days
Class 2
Risk

K220264 is an FDA 510(k) clearance for the EFAI RTSuite CT HN-Segmentation System. Classified as Radiological Image Processing Software For Radiation Therapy (product code QKB), Class II - Special Controls.

Submitted by Ever Fortune.Ai, Co., Ltd. (Taichung City, TW). The FDA issued a Cleared decision on April 28, 2022 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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

Submission Details

510(k) Number K220264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2022
Decision Date April 28, 2022
Days to Decision 87 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
20d faster than avg
Panel avg: 107d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QKB Radiological Image Processing Software For Radiation Therapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
Definition To Provide Semi-automatic Or Fully-automated Radiological Image Processing And Analysis Tools For Radiation Therapy. Software Implementing Artificial Intelligence (ai) Including Nonadaptive Machine Learning Algorithms Trained With Clinical And/or Artificial Radiological Images. In These Devices, The Algorithm Training Images Typically Impact Device Performance. Ai Based Radiological Image Processing Software Is Intended To Be Used In The Workflow Of Radiation Therapy. Adaptive Ai Algorithms Are Not Within The Scope Of This Product Code. Primary Radiation Dose Calculation Or Plan Optimization For Treatment Planning Are Not Within Scope Of This Product Code.
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.

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All 45
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