Cleared Traditional

Ligence Heart

K252105 · Ligence Uab · Radiology
Sep 2025
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K252105 is an FDA 510(k) clearance for the Ligence Heart, a Automated Radiological Image Processing Software (Class II — Special Controls, product code QIH), submitted by Ligence Uab (Kaunas, LT). The FDA issued a Cleared decision on September 26, 2025, 85 days after receiving the submission on July 3, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K252105 FDA.gov
FDA Decision Cleared SESE
Date Received July 03, 2025
Decision Date September 26, 2025
Days to Decision 85 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code QIH — Automated Radiological Image Processing Software
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050
Definition To Provide Automated Radiological Image Processing And Analysis Tools. Software Implementing Artificial Intelligence Including Nonadaptive Machine Learning Algorithms Trained With Clinical And/or Artificial Data. In These Devices, The Algorithm Training Data Typically Impacts Device Performance. Adaptive Ai Algorithms Are Not Within Scope Of This Product Code.