WRDensity by Whiterabbit.ai
K202013Whiterabbit.ai Inc. · cleared 2020-10-30 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“WRDensity is a software application intended for use with compatible full field digital mammography and digital breast tomosynthesis systems.”
source quote (p.4)
“WRDensity is a standalone software application that automatically analyzes "for presentation” data from digital breast x-ray systems with a deep learning algorithm to assess breast tissue composition.”
Validation studies (1)
Retrospective clinical
n=871 patients
endpoints: accuracy; quadratically-weighted Cohen's kappa; confusion matrices; agreement, in terms of percentage of cases; maximum root mean square error
standards: IEC 62304:2006/AC:2015 - Medical device software – Software life cycle processes, FDA guidance document,“Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.”
Reported performance (2 observations)
source quote (p.8)
“On the four-class task, WRDensity achieved a quadratically-weighted Cohen's kappa of 0.90, 95% confidence interval [0.88, 0.92].”
source quote (p.9)
“On the binary task, WRDensity achieved a Cohen's kappa of 0.88, 95% confidence interval [0.85, 0.91].”
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).