Qure.Ai Technologies radiology AI products

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FDA-cleared K251934

qXR-Detect

Qure.Ai Technologies

Authorized purpose: qXR-Detect is an adult chest-radiograph concurrent reading aid that identifies, highlights and categorizes suspicious regions of interest across lung, pleura, mediastinum/hila/heart, bone, hardware and other categories; trained clinicians remain responsible for primary interpretation.

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

Authorized purpose: 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

Quantification and segmentation Acute triage and notification

FDA-cleared K240740

qCT LN Quant

Qure.ai Technologies

Authorized purpose: Quantitative characterization and longitudinal tracking of user-detected solid pulmonary nodules at least 6 mm on chest CT.

Modality: CT/CTA
Anatomy: Chest and lungs
Decision: 2024-08-16

Lung nodule detection Detection and CADe Quantification and segmentation

FDA-cleared K231805

qXR-LN

Qure.ai Technologies

Authorized purpose: 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

Lung nodule detection Detection and CADe

FDA-cleared K231149

qXR-CTR

Qure.ai Technologies

Authorized purpose: Automated measurement of cardiac diameter, thoracic diameter, and the cardiothoracic ratio (CTR) on posterior-anterior chest X-rays to aid physicians or licensed practitioners; not a stand-alone decision tool.

Modality: X-ray/Radiography
Anatomy: Heart and thoracic cavity
Decision: 2023-09-22

Cardiac imaging Quantification and segmentation

FDA-cleared K230899

qXR-PTX-PE

Qure.ai Technologies

Authorized purpose: 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 triage within standard of care; results are not for standalone clinical decision-making or to rule out the target conditions.

Modality: X-ray/Radiography
Anatomy: Chest/Lung
Decision: 2023-08-22

Acute triage and notification

FDA-cleared K212690

qXR-BT

Qure.ai Technologies

Authorized purpose: Generate a secondary digital chest X-ray image to facilitate confirmation of breathing-tube position and the carina in adults.

Modality: X-ray/Radiography
Anatomy: Chest; target structures are the breathing tube and carina
Decision: 2021-12-21

X-ray/Radiography workflow

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 midline shift; single-timepoint volumes and longitudinal comparisons are provided when scans use the same scanner and protocol for the same person.

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

Stroke and ICH triage Quantification and segmentation

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 networks and trained medical specialists in workflow triage by flagging the following suspected positive findings of pathologies in head CT images: intracranial hemorrhage, mass effect, midline shift and cranial fracture. qER uses an artificial intelligence algorithm to analyze images on a Stand-Alone Performance cloud-based application in parallel to the ongoing standard of care image interpretation.

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

Stroke and ICH triage MSK and bone Acute triage and notification