BraveCX
K223754Bering Ltd · cleared 2023-11-09 · product code QFM · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.3)
“BraveCX is a radiological computer-assisted triage and notification software that analyzes adult (≥18 years old) chest X-ray images for the presence of pre-specified suspected critical findings (pleural effusion and/or pneumothorax).”
AlgorithmDeep Learning Artificial Intelligence (AI) software
source quote (p.9)
“BraveCX is a Deep Learning Artificial Intelligence (AI) software that was trained to detect pleural effusion and pneumothorax in chest X-Ray images.”
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)
Retrospective clinical
n=2,596 cases · 14 site(s)
Retrospective clinical
n=2,981 cases · 3 site(s)
standards: IEC 62304
Reported performance (7 observations)
sensitivity0.9262CI 90.67%-94.27%
source quote (p.14)
“Sensitivity 92.62% (95% CI:90.67%-94.27%)”
specificity0.9811CI 97.33%-98.71%
source quote (p.14)
“Specificity 98.11% (97.33%-98.71%).”
aurocas written: “auc”0.988CI 0.9885-0.9887
source quote (p.14)
“ROC AUC 0.988 (95% CI:0.9885-0.9887)”
aurocas written: “ROC AUC (Pneumothorax)”0.972CI 0.9727-0.9729
source quote (p.14)
“ROC AUC 0.972 (95% CI:0.9727-0.9729)”
sensitivityas written: “Sensitivity (Pneumothorax)”0.9338CI 92.23%-94.40%
source quote (p.14)
“Sensitivity 93.38% (95% CI:92.23%-94.40%)”
specificityas written: “Specificity (Pneumothorax)”0.9727CI 96.49%-97.92%
source quote (p.14)
“Specificity 97.27% (96.49%-97.92%).”
time_to_resultas written: “Time-to-notification”10.4CI 4.2-10.41s
source quote (p.15)
“Time-to-notification of BraveCX was 4.8 seconds-10.4 seconds (95% CI: 4.2-10.41s) for simultaneous prediction of Pleural Effusion and Pneumothorax.”
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).