Ligence Heart— 510(k) K261733

Name: FDA 510(k) clearance K261733
Creator: U.S. Food and Drug Administration
Published: 2026-10-07

Substantially Equivalent

UAB Ligence

FDA 510(k) clearance K261733 for Ligence Heart, Substantially Equivalent on 2026-10-07. Applicant: UAB Ligence. Device class: 2.

Summary

Ligence Heart from UAB Ligence is filed under QIH, automated radiological image processing software. The name ties it to cardiac imaging, but the record doesn't say which modality it works with or what it measures.

Class II, 21 CFR 892.2050. The Radiology panel reviewed it as a Traditional 510(k).

Ligence filed from Kaunas, Lithuania. Review took 134 days (May 26 to October 7, 2026).

Clearance details

Applicant: UAB Ligence
Product code: Product code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2026-05-26
Decision date: 2026-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kaunas, LT

Download summary PDF View on FDA.gov ↗

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