qER is an AI-powered software designed to analyze non-contrast head CT scans to detect critical conditions like intracranial hemorrhage, mass effect, midline shift, and cranial fractures. It assists clinicians by prioritizing urgent scans for review, helping to speed up diagnosis without altering the original image data.
Intended Use
qER is a radiological computer aided triage and notification software indicated for use in the analysis of non-contrast head CT images. It assists hospital networks and trained medical specialists in workflow triage by flagging suspected positive findings of intracranial hemorrhage, mass effect, midline shift, and cranial fracture. The software operates in parallel to the standard of care image interpretation and provides notifications for suspected findings to assist with triage and prioritization.
Technology
qER consists of an on-premise gateway interfacing with client PACS/worklist systems and a cloud or on-premise analysis module hosting pre-trained deep learning convolutional neural networks (CNNs). It processes non-contrast head CT DICOM images, applies four independent AI algorithms to detect each abnormality, and outputs triage results and preview images for notifications without altering the original medical images.
Performance
A retrospective, multicenter, blinded clinical study on 1320 head CT scans demonstrated high sensitivity (96.39%-98.53%) and specificity (91.22%-96.00%) for detecting intracranial hemorrhage, mass effect, midline shift, and cranial fractures. The software substantially reduced time to notify clinicians of critical scans from 65.54 minutes (standard care) to 2.11 minutes, supporting improved clinical workflow efficiency.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/6/2020
2 months - 2
FDA Approval
6/17/2020
Other devices from Qure.ai Technologies
- qCT LN Quant2024 • 510K
- qXR-LN2023 • 510K
- qXR-CTR2023 • 510K
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.