AIMI-Triage CXR PTX
K193300RADLogics, Inc. · cleared 2020-04-08 · product code QFM · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.3)
“The AIMI-Triage CXR PTX Application is 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. The device operates in parallel to and independent of standard of care image interpretation workflow. Specifically, the device uses an artificial intelligence algorithm to analyze images for features suggestive of moderate to large sized pneumothorax; it makes case-level output available to a PACS/workstation for worklist prioritization or triage.”
Algorithmartificial intelligence algorithm, trained via pattern recognition, processes each chest X-ray and flags those that appear to contain a moderate to large sized pneumothorax for urgent radiologist review
source quote (p.4)
“The artificial intelligence algorithm, trained via pattern recognition, processes each chest X-ray and flags those that appear to contain a moderate to large sized pneumothorax for urgent radiologist review.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this
Validation studies (1)
Retrospective clinical
n=300 images
endpoints: area under the curve (AUC); sensitivity; specificity
Reported performance (3 observations)
sensitivity0.92CI [86%, 96%]
source quote (p.5)
“The sensitivity and specificity of the device was 92% (95% CI: [86%, 96%]) and 90% (95% CI: [84%, 95%]), respectively.”
specificity0.9CI [84%, 95%]
source quote (p.5)
“The sensitivity and specificity of the device was 92% (95% CI: [86%, 96%]) and 90% (95% CI: [84%, 95%]), respectively.”
aurocas written: “auc”0.967CI [95.0%, 98.4%]
source quote (p.5)
“Overall, the device was able to demonstrate an area under the curve (AUC) of 96.7% (95% CI: [95.0%, 98.4%]), which is substantially equivalent to the predicate device, and meets the required performance goal.”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).