Identifiers
- 510(k) Number
- K192969 FDA 510(k)
- FDA Product Code
- QIH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Ezra Plexo Software is a medical imaging application designed to help radiologists view, manipulate, and compare 2D and 3D MR images through a web browser. It supports oncological workflows by enabling visualization, evaluation, quantification, and documentation of lesions, facilitating better clinical assessment and decision-making.
The device is supplied as a cloud-based PACS platform, allowing radiologists to use Ezra's AI platform without software installation. It is intended for use in outpatient imaging facilities and includes integration with custom EHR, booking systems, patient portals, and imaging viewers. The device received FDA 510(k) clearance (K192969) on July 10, 2020, and is classified under product code QIH with review by the Radiology advisory committee.
Frequently asked questions
What is Ezra Plexo Software used for?
Ezra Plexo Software is a medical imaging application designed to help radiologists view, manipulate, and compare 2D and 3D MR images through a web browser. It supports oncological workflows by enabling visualization, evaluation, quantification, and documentation of lesions, facilitating better clinical assessment and decision-making.
How is Ezra Plexo Software supplied and accessed?
Ezra Plexo Software is supplied as a cloud-based PACS platform, allowing radiologists to use Ezra's AI platform without software installation. It is accessed via a web browser and intended for use in outpatient imaging facilities.
Does Ezra Plexo Software integrate with other systems?
Yes, Ezra Plexo Software includes integration with custom EHR, booking systems, patient portals, and imaging viewers, enabling seamless workflow connectivity within outpatient imaging facilities.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Ezra Plexo Software | FDA Radiology AI Device, Ezra Plexo - Physician AI Tools, Ezra Plexo Software | Ezra AI Inc. radiology AI profile
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192969 | Class II | Active |
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Manufacturer
- Manufacturer
- Ezra Ai, Inc.
Sources (1)
- FDA 510(k) K192969 24 fields · synced Sep 22, 2026