Ezra Plexo Software

K192969

Ezra AI Inc. · cleared 2020-07-10 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“Ezra Plexo is a medical image application for 2D and 3D visualization, comparison, and manipulation of medical images. Plexo does not interface directly with the MR scanner or any other data collection equipment. Instead, it uploads data files previously generated by such equipment.”
AlgorithmFDA source did not state this
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedFDA source did not state this

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

0
recalls in product code, 24mo
3
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); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K192969