Ezra Plexo Software
K192969Ezra AI Inc. · cleared 2020-07-10 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“Ezra Plexo Software is a medical diagnostic application for viewing, manipulation, 3D- visualization, and comparison of MR medical images.”
source quote (p.5)
“The product allows volumetric segmentation of regions of interest, while enabling users to edit such segmentations and to take quantitative measurements.”
Validation studies (1)
Retrospective clinical
n=150 patients
standards: ISO 14971:2007- Medical devices - Application of risk management to medical devices, IEC 62304:2006/A1:2015 - Medical device software - Software life cycle processes, IEC 62366-1:2015 - Medical Devices - Application of usability engineering to medical devices, NEMA PS 3.1-3.20 (2016) - Digital Imaging and Communications in Medicine (DICOM) set
Reported performance (0 observations)
FDA source did not state a quantitative performance metric — non-reporting is itself the signal.
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).