Radiology AI Directory

FDA-cleared profile

Ezra Plexo Software

Ezra AI Inc.

Ezra Plexo Software is a medical diagnostic application for viewing, manipulation, three-dimensional visualization, and comparison of MR medical images. It supports an oncologic workflow by helping the user confirm the absence or presence of lesions, including evaluation, quantification, and documentation; the clinician retains responsibility for diagnosis and the software complements standard review of separate unregistered images.

Quantification and segmentation
Evidence status: each field shows source quality, applicability, and review date. Research pending, information not established in reviewed sources, and vendor documentation pending are distinct outcomes.

Clinical fit

What this tool is for

Start with the authorized purpose, then verify how it fits your service line and reading workflow.

Exact purpose
Ezra Plexo Software is a medical diagnostic application for viewing, manipulation, three-dimensional visualization, and comparison of MR medical images. It supports an oncologic workflow by helping the user confirm the absence or presence of lesions, including evaluation, quantification, and documentation; the clinician retains responsibility for diagnosis and the software complements standard review of separate unregistered images.
FDA source Exact FDA submission Checked 2026-09-04
Intended users
Radiologists, physicians, technologists, and other trained medical professionals within the labeled workflow.
FDA source Exact FDA submission Checked 2026-09-04
Care setting and population
Clinical image-review, reporting, planning, or post-processing environments within the labeled scope.
FDA source Exact FDA submission Checked 2026-09-04
Workflow role
Medical-image display, manipulation, segmentation, quantification, comparison, reporting, or workflow support under professional review.
FDA source Exact FDA submission Checked 2026-09-04
Required input
Supported DICOM images, image metadata, patient data, and user inputs from the labeled imaging devices.
FDA source Exact FDA submission Checked 2026-09-04
Output and human action
Displayed images, reformats, segmentations, measurements, annotations, reports, and workflow records for professional review.
FDA source Exact FDA submission Checked 2026-09-04
Limitations
The exact labeling is for MR-image review and an oncologic complement to standard practice; it does not replace primary interpretation or establish a product-wide lesion-detection performance claim.
FDA source Exact FDA submission Checked 2026-09-04

Regulatory identity

FDA record and catalog context

The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.

FDA submission
K192969
FDA source Exact FDA submission Checked 2026-08-31
Modality
MRI
FDA source Exact FDA submission Checked 2026-09-04
Anatomy
MR images and lesions in oncologic imaging
FDA source Exact FDA submission Checked 2026-09-04
Clearance type
510(k)
FDA source Exact FDA submission Checked 2026-08-31
Decision date
2020-07-10
FDA source Exact FDA submission Checked 2026-08-31
FDA status
FDA-cleared
FDA source Exact FDA submission Checked 2026-08-31

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration
Standards-based DICOM/PACS integration was identified in the FDA submission materials; compatibility with a specific PACS, RIS, EHR, or orchestrator requires confirmation.
Public source Exact FDA submission Checked 2026-08-13

Normalized from the prior exact-submission review. Confirm interface versions and local compatibility during technical evaluation.

Deployment and data flow
On-premise
Public source Exact FDA submission Checked 2026-08-13

Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.

Security and privacy
Not established in reviewed sources
Reviewed sources checked Exact FDA submission Checked 2026-09-04

Public materials reviewed for this exact release do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.

Training and support
Only radiologists, physicians, technologists, and other trained medical professionals within the labeled workflow should operate or interpret the product. Local onboarding should cover the exact release, supported population, limitations, failure examples, escalation, downtime, and competency documentation.
FDA source Exact FDA submission Checked 2026-09-04
Monitoring and change control
Monitor K192969 by exact hardware, software, model, and algorithm version; patient population; anatomy; protocol; operator; input quality; output edits or overrides; failed studies; repeat acquisition or rework; downstream impact; downtime; incidents; recalls; and updates. Track these product-specific limits: The exact labeling is for MR-image review and an oncologic complement to standard practice; it does not replace primary interpretation or establish a product-wide lesion-detection performance claim.
FDA source Exact FDA submission Checked 2026-09-04

This is buyer-facing monitoring guidance derived from the exact cleared scope; it is not a claim that the FDA package provides a live monitoring service.

Release and scope verification

Map installed model, build, options, population, anatomy, inputs, outputs, and enabled functions to K192969 before acceptance.

exact submission · checked 2026-09-04

Later product-family features are not evidence that this cleared or authorized release includes them.

Source

Deployment boundary

The exact public deployment topology remains incomplete; establish hosting responsibility, data flow, availability, upgrade, service, and downtime boundaries locally.

exact submission · checked 2026-09-04

FDA-described topology does not establish current hosting contracts, security controls, uptime, or local qualification.

Source

Interoperability acceptance

The exact public integration contract remains incomplete; establish and test supported input, output, identity, routing, archive, and downtime behavior locally.

exact submission · checked 2026-09-04

Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally.

Source

Clinical acceptance

Use a signed local test set for the supported population and workflow. Include common and difficult cases, exclusions, acquisition variation, failed or low-quality inputs, reviewer overrides, and downstream effects. The exact labeling is for MR-image review and an oncologic complement to standard practice; it does not replace primary interpretation or establish a product-wide lesion-detection performance claim.

exact submission · checked 2026-09-04

Define stop-use, escalation, rollback, and revalidation triggers before production use.

Source

Economic evaluation

Model capital and recurring cost against net staff time after review, throughput, repeat imaging or rework, room time, consumables, infrastructure, training, service, downtime, upgrade, and replacement costs.

exact submission · checked 2026-09-04

No exact-product price or reimbursement determination was promoted.

Source

Lifecycle monitoring

Monitor K192969 by exact hardware, software, model, and algorithm version; patient population; anatomy; protocol; operator; input quality; output edits or overrides; failed studies; repeat acquisition or rework; downstream impact; downtime; incidents; recalls; and updates. Track these product-specific limits: The exact labeling is for MR-image review and an oncologic complement to standard practice; it does not replace primary interpretation or establish a product-wide lesion-detection performance claim.

exact submission · checked 2026-09-04

Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes.

Source

Evidence

Performance evidence

Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.

Evidence summary
K192969 FDA decision material identifies the exact cleared or authorized product, intended use, labeled anatomy and modality, and submission-specific verification. It does not by itself establish product-wide sensitivity, specificity, outcomes, reimbursement, or independent clinical validation for this exact configuration.
FDA source Exact FDA submission Checked 2026-09-04
Reported sensitivity
Not applicable
Not applicable Not applicable Checked 2026-09-04

Sensitivity is not promoted as a product-wide endpoint. Compare only an exact endpoint, threshold, population, version, study design, and source if separately verified.

Reported specificity
Not applicable
Not applicable Not applicable Checked 2026-09-04

Specificity is not promoted as a product-wide endpoint. Compare only an exact endpoint, threshold, population, version, study design, and source if separately verified.

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

K192969 FDA decision evidence package for Ezra Plexo Software

FDA decision evidence and product verification described in the exact submission or PMA decision record. · MR images and lesions in oncologic imaging

exact submission · Tested version: Ezra Plexo Software configuration described in K192969 · Sponsor or vendor study

K192969

FDA decision material is manufacturer-submitted regulatory evidence. It is not independent clinical validation unless the exact source expressly establishes that distinction; local technical, clinical, privacy, security, and workflow acceptance remains necessary.

Source

Economics and lifecycle

Budget and ongoing governance

These are common procurement questions; unknown values remain visible until a source supports them.

Pricing and total cost
Not established in reviewed sources
Reviewed sources checked Exact FDA submission Checked 2026-09-04

No public list price for the exact cleared or authorized configuration was found. Obtain a written quote separating license or hardware basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.

Reimbursement and coding
Not established in reviewed sources
Reviewed sources checked Exact FDA submission Checked 2026-09-04

No exact-product reimbursement determination was promoted in this timeboxed review. Verify payer, site-of-service, coding, coverage, and local payment assumptions independently.

Safety and lifecycle

Postmarket record

Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.

Postmarket safety review
The 2026-09-02 openFDA device-recall snapshot contained no record matched to K192969 by exact native submission identifier. This does not exclude product-family, later-version, or adverse-event information.
Public source Exact FDA submission Checked 2026-09-04

Exact-identifier review does not prove absence of all product-family safety signals.

Buyer worksheet

Open questions to take to the vendor

Open evaluation checklist

Research record

What has been checked

This audit distinguishes completed source review from fields that have not yet been researched.

Exact FDA record reviewedStatus
2026-09-04Last searched
26Fields reviewed
7Source classes checked
0Unreviewed PubMed leads
0Unreviewed trial leads
0Unreviewed FDA recall leads

Recovered from the prior exact-submission extraction and normalized under the current provenance rules. Scope was limited to exact FDA decision material and exact-submission recall disposition already present in the checked snapshot. Optional literature, vendor, pricing, and deployment research was not promoted. Automated exact-name discovery found 0 PubMed and 0 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads remain unpublished until a human confirms the exact product and tested version.

Source classes: fda ai list, fda decision summary, fda decision material, fda device recall, pubmed, clinical trials, openfda device recall

Sources

Source ledger

Sources accessed through 2026-09-04.

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