Red Dot
K191556Behold.AI Technologies Limited · cleared 2020-02-28 · product code QFM · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.5)
“The red dot™ software platform is a software workflow tool designed to aid the clinical assessment of adult Chest X-Ray cases with features suggestive of Pneumothorax in the medical care environment. red dot™ analyzes cases using an artificial intelligence algorithm to identify suspected findings.”
Algorithmvisual recognition algorithm using Artificial Intelligence (AI) and pattern recognition technology
source quote (p.5)
“This component of the device is primarily comprised of the visual recognition algorithm that is responsible for detecting images with potential abnormalities. Once a study has been validated, the algorithm analyzes the frontal chest x-ray for detection of suspected findings suggestive of pneumothorax. Behold.ai red-dot™ tool uses Artificial Intelligence (AI) and pattern recognition technology to analyze chest X-rays.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo
Validation studies (1)
Retrospective clinical
n=888 images · 4 site(s)
endpoints: AUROC; Accuracy; Sensitivity; Specificity; Processing time; Notification transit time; red dot performance time
Reported performance (4 observations)
sensitivity0.9465CI [91.46 – 96.91]
source quote (p.8)
“Sensitivity: 94.65% (283/299) with 95% confidence interval: [91.46 – 96.91]”
specificity0.8795CI [85.04 – 90.46]
source quote (p.8)
“Specificity: 87.95% (518/589) with 95% confidence interval: [85.04 – 90.46]”
aurocas written: “auc”0.975CI [0.966 - 0.984]
source quote (p.8)
“AUROC: 0.975 with 95% confidence intervals [0.966 - 0.984]”
accuracyas written: “Accuracy”0.902CI [88.06 – 92.08]
source quote (p.8)
“Accuracy: 90.20% (801/888) with 95% confidence interval: [88.06 – 92.08]”
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).