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qXR-CTR

by Qure.Ai Technologies 510(k)

Active United States

510(k) K231149

Overview

qXR-CTR is a deep learning-based computer vision algorithm designed to automate the assessment of the cardiothoracic ratio (CTR) on chest radiographs. It is engineered to assist in identifying radiographic markers associated with cardiomegaly and heart failure risk.

The device received FDA 510(k) clearance (K231149) on September 22, 2023, and is substantially equivalent to a predicate device. It is supplied as a software-only medical device for use in radiology settings, with no indication of sterility, single-use or reusable status, MRI safety, or physical sizes provided in the data.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK231149 Date22 Sep 2023ClearedStatusActive

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
QIH
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Other devices from Qure.Ai Technologies

  • qXR-LN

    Class II

  • qER

    Class II

  • qXR-BT

    Class II

  • qXR-PTX-PE

    Class II

  • qXR-Detect

    Class II

  • qCT LN Quant

    Class II

See all devices from Qure.Ai Technologies →

Questions

  • What is qXR-CTR used for?

    qXR-CTR is designed to automate the assessment of the cardiothoracic ratio (CTR) on chest radiographs using deep learning-based computer vision, assisting in identifying radiographic markers associated with cardiomegaly and heart failure risk.

  • How is qXR-CTR supplied and what type of device is it?

    qXR-CTR is supplied as a software-only medical device intended for use in radiology settings, with no physical components, sterility, single-use, or reusable characteristics applicable due to its digital nature.

  • Does qXR-CTR have any physical size, storage, or MRI safety requirements?

    As a software-only device, qXR-CTR has no physical size, storage conditions, or MRI safety specifications provided in the data, as it operates digitally within compatible radiology systems.