Radify Triage
K231871Envisionit DeepAI Ltd · cleared 2024-01-17 · product code QFM · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.3)
“RADIFY® Triage is a radiological computer-assisted triage and notification software that analyzes adult chest X-ray images for the presence of pre-specified suspected critical findings (pleural effusion and/or pneumothorax). RADIFY® Triage uses an artificial intelligence algorithm to analyze images for features suggestive of critical findings and provides case-level output available in the PACS for worklist prioritization or triage.”
AlgorithmArtificial Intelligence Algorithm(s) – Deep Convolutional Neural Networks (DCNN)
source quote (p.5)
“RADIFY® Triage and the identified predicate device(s) are software-only devices that use Artificial intelligence (AI) algorithms and are intended to aid in triage and prioritization of radiological images. Both RADIFY® Triage and Lunit Insight (Primary Predicate) have the same principles of operation and underlying technological characteristics: 1. Artificial Intelligence Algorithm(s) – Deep Convolutional Neural Networks (DCNN)”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this
Validation studies (2)
Bench
sample size not stated
Retrospective clinical
n=1,229 scans · 4 site(s)
endpoints: AUC; Sensitivity; Specificity
Reported performance (3 observations)
sensitivity0.9426CI 93.53, 94.99
source quote (p.13)
“94.26 95% CI (93.53, 94.99)”
specificity0.9727CI 96.54, 98.00
source quote (p.13)
“97.27 95% CI (96.54, 98.00)”
aurocas written: “auc”0.9762CI 97.43 97.81
source quote (p.13)
“97.62 95% CI (97.43 97.81)”
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).