Avara Viewer— 510(k) K262120

Name: FDA 510(k) clearance K262120
Creator: U.S. Food and Drug Administration
Published: 2026-07-10

Substantially Equivalent

Avara Software

FDA 510(k) clearance K262120 for Avara Viewer, Substantially Equivalent on 2026-07-10. Applicant: Avara Software. Device class: 2.

Summary

Avara Software's Avara Viewer is filed under LLZ, radiological image processing systems. The record doesn't describe what the viewer does beyond that code name.

Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel. It came in as a Traditional 510(k).

Avara Software filed from St Petersburg, Florida. Review took 17 calendar days (June 23 to July 10, 2026). The record flags it as a third-party review.

Clearance details

Applicant: Avara Software
Product code: Product code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2026-06-23
Decision date: 2026-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St Petersburg, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.