FDA-cleared K251934

qXR-Detect

Qure.Ai Technologies

qXR-Detect is an adult chest-radiograph concurrent reading aid that identifies, highlights and categorizes suspicious regions of interest across lung, pleura,...

Modality
X-ray/Radiography
Anatomy
Chest/Lung; pleura, mediastinum/hila/heart, bone, hardware and other chest-radiograph regions
Decision
2026-01-16
FDA-cleared K251610

qER-CTA (v1.0)

Qure.ai Technologies

Parallel notification of suspected anterior-circulation large vessel occlusion on acute head CTA for specialist review; notification only, not diagnosis.

Modality
CT/CTA
Anatomy
Brain anterior circulation: internal carotid artery and M1 segment of the middle cerebral artery
Decision
2025-09-08
FDA-cleared K231805

qXR-LN

Qure.ai Technologies

Second-reader CADe to identify and mark suspected pulmonary nodules 6-30 mm in the incidental adult population

Modality
X-ray/Radiography
Anatomy
Chest/lung, focused on suspected pulmonary nodules
Decision
2023-12-22
FDA-cleared K231149

qXR-CTR

Qure.ai Technologies

Automated measurement of cardiac diameter, thoracic diameter, and the cardiothoracic ratio (CTR) on posterior-anterior chest X-rays to aid physicians or licensed practitioners;...

Modality
X-ray/Radiography
Anatomy
Heart and thoracic cavity
Decision
2023-09-22
FDA-cleared K230899

qXR-PTX-PE

Qure.ai Technologies

Analyze adult frontal chest X-ray images for suspected pleural effusion and/or pneumothorax and provide case-level passive output for PACS/workstation worklist prioritization or...

Modality
X-ray/Radiography
Anatomy
Chest/Lung
Decision
2023-08-22
FDA-cleared K212690

qXR-BT

Qure.ai Technologies

The qXR-BT device is intended to generate a secondary digital chest X-ray image that facilitates confirmation of the position of a breathing tube and an anatomical landmark on...

Modality
X-ray/Radiography
Anatomy
Chest/Lung
Decision
2021-12-21
FDA-cleared K211222

qER-Quant

Qure.ai Technologies

Automatic labeling, visualization, and quantification of segmentable brain structures from non-contrast head CT, including intracranial hyperdensities, lateral ventricles, and...

Modality
CT/CTA
Anatomy
Brain; intracranial hyperdensities, lateral ventricles, and midline shift
Decision
2021-07-30
FDA-cleared K200921

qER

Qure.ai Technologies

qER is a radiological computer aided triage and notification software indicated for use in the analysis of non-contrast head CT images. The device is intended to assist hospital...

Modality
CT/CTA
Anatomy
Brain
Decision
2020-06-17