BraveCX

K223754

Bering 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.6)
“BraveCX is a Deep Learning Artificial Intelligence (AI) 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)”
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=1,209 cases · 14 site(s)

endpoints: pleural effusion; pneumothorax

Retrospective clinical

n=867 cases · 3 site(s)

endpoints: pleural effusion; pneumothorax

standards: IEC 62304/FDA Guidance

Reported performance (7 observations)

sensitivity0.9262CI [90.67%, 94.27%]
source quote (p.11)
“Sensitivity 92.62% (95% CI : [90.67%, 94.27%])”
specificity0.9811CI [97.33%, 98.71%]
source quote (p.11)
“Specificity 98.11% (95% CI [97.33%, 98.71%])”
aurocas written: “auc”0.988CI [0.988, 0.9887]
source quote (p.11)
“AUC: 0.988 (95% CI: [0.988, 0.9887]”
aurocas written: “Pneumothorax AUC”0.972CI [0.9727, 0.9729]
source quote (p.11)
“AUC : 0.972 (95% CI: [0.9727, 0.9729])”
sensitivityas written: “Pneumothorax Sensitivity”0.9338CI [92.23%, 94.40%]
source quote (p.11)
“Sensitivity 93.38% (95% CI: [92.23%, 94.40%])”
specificityas written: “Pneumothorax Specificity”0.9727CI [96.49%-97.92%]
source quote (p.11)
“Specificity 97.27% (95%CI: [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); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K223754