Cleerly LABS— 510(k) K260588

Name: FDA 510(k) clearance K260588
Creator: U.S. Food and Drug Administration
Published: 2026-07-29

Substantially Equivalent

Cleerly, Inc.

FDA 510(k) clearance K260588 for Cleerly LABS, Substantially Equivalent on 2026-07-29. Applicant: Cleerly, Inc.. Device class: 2.

Summary

Cleerly LABS from Cleerly is filed under LLZ, radiological image processing systems. The record doesn't expand "LABS" or describe what the system 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).

Cleerly filed from Denver, Colorado. Review took 159 calendar days (February 20 to July 29, 2026).

Clearance details

Applicant: Cleerly, Inc.
Product code: Product code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2026-02-20
Decision date: 2026-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denver, CO, 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.