Seg Pro V3 (RT-300) is an AI-enabled medical device from Ever Fortune.Ai, Co., Ltd. that the U.S. FDA cleared through 510(k) K251306 on January 28, 2026. Its lead review panel is Radiology and its primary product code is QKB (Radiological Image Processing Software For Radiation Therapy).

Submission number

K251306

Pathway

510(k)

Date of final decision

January 28, 2026

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. Seg Pro V3 (RT-300) went through this pathway (K251306).

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 #42 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.

Seg Pro V3 (RT-300)

Key facts

What this means

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