AIMI-Triage CXR PTX
RADLogics, Inc.AIMI-Triage CXR PTX by RADLogics is an FDA-cleared AI software that helps hospital radiologists prioritize adult chest X-rays that might show moderate to large pneumothorax. It analyzes chest X-rays and flags urgent cases for quicker review, improving workflow and patient care by notifying radiologists of possible urgent findings without replacing full diagnosis.
Intended Use
A notification-only triage workflow tool for use by hospital networks and clinics to identify and help prioritize chest X-rays acquired in the acute setting for review by hospital radiologists. Uses an AI algorithm to analyze images for features suggestive of moderate to large pneumothorax and makes case-level output available for worklist prioritization or triage. Not for diagnostic use beyond notification and does not replace full patient evaluation or diagnosis.
Technology
AI algorithm trained on pattern recognition to detect moderate to large pneumothorax from chest X-rays. The software integrates with hospital PACS to analyze images and flag suspected cases for urgent review without altering original images or removing cases from the worklist. The output is compatible with any PACS viewer and worklist.
Performance
Evaluated in a blinded, retrospective, multi-center study with 300 frontal chest X-rays. Achieved an area under the curve (AUC) of 96.7% with sensitivity of 92% and specificity of 90%. Performance comparable to predicate device with an average notification time of 20.3 seconds.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/27/2019
4 months - 2
FDA Approval
4/8/2020
Other devices from RADLogics, Inc.
- ALPHAPOINT IMAGING SOFTWARE2012 • 510K
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