Skip to content

qER

by Qure.Ai Technologies 510(k)

Active United States

510(k) K200921

Overview

qER is a radiological computer-assisted triage and notification software. It is an AI-powered software for automated analysis and quantification of non-contrast head CT images, aiding in the assessment and monitoring of neurological conditions.

The device is supplied as software and is not specified as single-use or reusable. It has FDA 510K clearance with product code QAS and is classified as a class II medical device. The device is intended for use in radiology settings.

AI-generated from registry data, 24 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK200921 Date17 Jun 2020ClearedStatusActive

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
QAS
Device Class
Class II
Regulation
21 CFR Part 892.2080
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Other devices from Qure.Ai Technologies

  • qXR-LN

    Class II

  • qXR-CTR

    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 qER used for?

    qER is a radiological computer-assisted triage and notification software that uses AI to analyze and quantify non-contrast head CT images, helping with the assessment and monitoring of neurological conditions in radiology settings.

  • How is qER supplied?

    qER is supplied as software without specification of single-use or reusable status. It is designed for use in radiology departments as a tool to assist with CT image analysis.

  • What is the regulatory status of qER?

    qER has FDA 510K clearance with product code QAS and is classified as a class II medical device. It received traditional clearance on June 17, 2020, as substantially equivalent.

  • What are the specifications of qER?

    qER is an AI-powered software specifically designed for automated analysis and quantification of non-contrast head CT images. It is manufactured by Qure.Ai Technologies and intended for use in radiology settings.