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Seg Pro V3 (RT-300)

by Ever Fortune.Ai, Co., Ltd. 510(k)

Active United States

510(k) K251306

Overview

Seg Pro V3 (RT-300) is a radiological image processing software for radiation therapy. This device is designed to assist in the planning and processing of images for radiation therapy procedures.

The device is manufactured by Ever Fortune.Ai, Co., Ltd. and is supplied as a Class II medical device. It has received FDA 510(k) clearance with K-number K251306 and is intended for use in radiology settings. The device is not specified as single-use or reusable, and no information regarding MRI safety or storage conditions is provided.

AI-generated from registry data, 22 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK251306 Date28 Jan 2026ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
QKB
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Seg Pro V3 (RT-300) used for?

    The Seg Pro V3 (RT-300) is a radiological image processing software designed to assist in the planning and processing of images for radiation therapy procedures. It helps clinicians prepare and analyze images for radiation therapy treatments.

  • How is the Seg Pro V3 (RT-300) supplied?

    The Seg Pro V3 (RT-300) is supplied as a Class II medical device manufactured by Ever Fortune.Ai, Co., Ltd. It is not specified whether the device is single-use or reusable in the provided information.

  • What regulatory approvals does the Seg Pro V3 (RT-300) have?

    The Seg Pro V3 (RT-300) has received FDA 510(k) clearance with K-number K251306. It is classified as a Class II medical device and is intended for use in radiology settings. The device has been determined to be substantially equivalent to predicate devices.

  • Are there different models or sizes available for the Seg Pro V3 (RT-300)?

    The provided information does not specify different models or sizes for the Seg Pro V3 (RT-300). The device is identified by its model number RT-300, but no variations in size or model configurations are mentioned in the device data.