# K192969: Ezra Plexo Software

- Pathway: 510(k) (Traditional)
- Applicant: Ezra Ai, Inc.
- Decided: Jul 10, 2020 after 261 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K913770 (1991). 94 ancestors in all.
No later device cites it as a predicate yet.
0 of 95 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173542: Arterys Oncology DL, Arterys, Inc. (2018) Summary page 4.

## Indications for use
Ezra Plexo Software is a medical diagnostic application for viewing, manipulation, 3D- visualization, and comparison of MR medical images. The images can be viewed in a number of output formats including volume rendering. Ezra Plexo Software enables visualization of information that would otherwise have to be visually compared disjointedly. Ezra Plexo Software is designed to support the oncological workflow by helping the user to confirm the absence or presence of lesions, including evaluation, quantification, and documentation of any such lesions. Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. Ezra Plexo Software is a complement to these standard procedures.

Source page: https://510kreport.com/device/K192969
Methodology: https://510kreport.com/methodology