Cleared Traditional

K261733 - Ligence Heart

K261733 is an FDA 510(k) clearance for Ligence Heart, manufactured by UAB Ligence. The device is a Class 2 Radiology device with product code QIH cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K261733 · UAB Ligence · Radiology device
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Oct 2026
Decision
134d
Days
Class 2
Risk

K261733 is an FDA 510(k) clearance for the Ligence Heart. Classified as Automated Radiological Image Processing Software within the QIH classification (a category dominated by AI-based automated radiology processing systems), Class II - Special Controls.

Submitted by UAB Ligence (Kaunas, LT). The FDA issued a Cleared decision on October 7, 2026 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

FDA 510(k) Submission Details - K261733

510(k) Number K261733 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2026
Decision Date October 07, 2026
Days to Decision 134 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 107d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QIH Device Classification - Class 2, Special Controls

Product Code QIH Automated Radiological Image Processing Software
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - QIH Automated Radiological Image Processing Software

All 333
Devices cleared under the same product code (QIH) and FDA review panel - the closest regulatory comparables to K261733.
CINA-Aneurysm+
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NeuroDR
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QGuideCT (1.0)
K260523 · Medis Medical Imaging Systems BV · Oct 2026
syngo.CT Brain Quantification
K260055 · Siemens Medical Solutions USA, Inc. · Sep 2026
BoneXpert
K262390 · Visiana · Sep 2026
Rapid Platform (R6.7)
K261368 · Ischemaview, Inc. · Sep 2026
K261733 · Ligence Heart
Download PDF UAB Ligence