ClearRead Xray Pneumothorax
K213566Riverain Technologies, Inc. · cleared 2022-03-10 · product code QFM · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“ClearRead Xray Pneumothorax is a notification-only triage workflow tool for use by trained professionals to help prioritize chest X-rays. 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 a pneumothorax 5 mm or larger; it makes case-level output available to a PACS/workstation for worklist prioritization or triage.”
source quote (p.6)
“Machine learning and image processing”
source quote (p.10)
“Secondly, by forcing the system to strongly detect local patterns of pneumothorax, the final decision is based on clinically meaningful structure, and not spurious information – age, gender, or ethnicity - as might be learned if just image labels were used.”
Validation studies (1)
Retrospective clinical
n=1,138 cases
endpoints: overall assessment of the possible presence of a PTX, without localization; AUC-ROC; sensitivity; specificity; time-to-notification
standards: IEC 62304:2006/AMD1:2015, EC62366-1:2015, ISO14971:2007
Reported performance (4 observations)
source quote (p.7)
“Sensitivity 0.922”
source quote (p.7)
“Specificity 0.951”
source quote (p.7)
“AUC 0.974”
source quote (p.7)
“Time to Notification 9.73 seconds”
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
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).