Bladder AI (AIBV01)
K230497Exo Inc · cleared 2023-06-22 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“Bladder AI is a standalone software as a medical device (SaMD) that helps qualified users with image-based assessment of bladder ultrasound images in patients aged 2 or older.”
source quote (p.3)
“Bladder Al uses machine-learning techniques to aid in the quantification of bladder volume from ultrasound images.”
Validation studies (1)
Retrospective clinical
n=122 patients
endpoints: intraclass correlation coefficient (ICC); 2-sided 95% Confidence Interval of the Bladder Volume error
standards: IEC 62304:2006/AC:2015 - Medical device software – Software life cycle processes, FDA Guidance (May 2005), “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices”, FDA Guidance (June 2022) “Technical performance assessment of quantitative imaging in radiological device premarket submissions"
Reported performance (2 observations)
source quote (p.8)
“Bladder volume, Dual-View 2 mL (LoA: -42 to 46) 0.98”
source quote (p.8)
“Bladder volume, Single-View 3 mL (LoA: -49 to 55) 0.97”
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).