EFAI RTSuite CT HN-Segmentation System is an AI-enabled medical device from Ever Fortune.AI Co., Ltd. that the U.S. FDA cleared through 510(k) K220264 on April 28, 2022. Its lead review panel is Radiology and its primary product code is QKB (Radiological Image Processing Software For Radiation Therapy).

Submission number

K220264

Pathway

510(k)

Date of final decision

April 28, 2022

Company (FDA list)

Ever Fortune.AI Co., Ltd.

Lead review panel

Radiology

Primary product code

QKB — Radiological Image Processing Software For Radiation Therapy

Applicant (openFDA)

Ever Fortune.Ai, Co., Ltd.

Applicant location

Taichung City, TW

Device class

Class 2

Regulation number

21 CFR 892.2050

Decision code

SESE

Submission type

Traditional

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. EFAI RTSuite CT HN-Segmentation System went through this pathway (K220264).

openFDA lists it as a Class 2 device under 21 CFR 892.2050. Class II devices are moderate risk and are subject to general and special controls.

Product code QKB covers 46 devices on the FDA AI list. By decision date, this device is #16 of 46 under that code. Ever Fortune.AI Co., Ltd. has 10 AI-enabled devices on the list, and the Radiology panel accounts for 1,230 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

EFAI RTSuite CT HN-Segmentation System

Key facts

What this means

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