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DrAid for Liver Segmentation

by Vinbrain Joint Stock Company

510(k) K241543

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK241543 Date6 Dec 2024ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

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

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

DrAid for Liver Segmentation is an AI-enabled medical software designed to assist healthcare professionals in analyzing liver images from CT scans. It provides semi-automated liver segmentation and tools for manual refinement and lesion identification to support evaluation and treatment planning.

The device is supplied as a web-based software application and is intended for use in clinical settings. It is not reusable and requires proper storage conditions. The device has received FDA 510(k) clearance and is listed in the FDA's Artificial Intelligence-Enabled Medical Devices list.

Other devices from Vinbrain Joint Stock Company

Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is DrAid for Liver Segmentation used for?

    DrAid for Liver Segmentation is an AI-enabled medical software designed to assist healthcare professionals in analyzing liver images from CT scans. It provides semi-automated liver segmentation and tools for manual refinement and lesion identification to support evaluation and treatment planning.

  • How is DrAid for Liver Segmentation supplied and what are its storage requirements?

    The device is supplied as a web-based software application intended for use in clinical settings. It is not reusable and requires proper storage conditions to maintain functionality and data integrity.

  • What regulatory approvals has DrAid for Liver Segmentation received?

    DrAid for Liver Segmentation has received FDA 510(k) clearance and is listed in the FDA's Artificial Intelligence-Enabled Medical Devices list. It was cleared through the traditional pathway with a decision code of SESE (Substantially Equivalent) by the Radiology Advisory Committee.

  • What models or versions of DrAid for Liver Segmentation are available?

    The device is identified by the model name DrAid™ for Liver Segmentation with the FDA product code QIH and K-number K241543. No other models or versions are specified in the available information.