Cleared Traditional

K143176 - UltraLinq

K143176 is an FDA 510(k) clearance for UltraLinq, manufactured by Ultralinq Healthcare Solutions, Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K143176 · Ultralinq Healthcare Solutions, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2015
Decision
255d
Days
Class 2
Risk

K143176 is an FDA 510(k) clearance for the UltraLinq. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Ultralinq Healthcare Solutions, Inc. (New York, US). The FDA issued a Cleared decision on July 17, 2015 after a review of 255 days - an extended review cycle.

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-to-high 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.

View all Ultralinq Healthcare Solutions, Inc. devices

FDA 510(k) Submission Details - K143176

510(k) Number K143176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2014
Decision Date July 17, 2015
Days to Decision 255 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
148d slower than avg
Panel avg: 107d · This submission: 255d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLZ Device Classification - Class 2, Special Controls

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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 - LLZ System, Image Processing, Radiological

All 1204
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K143176.
syngo.MR Neurology, syngo.MR Oncology
K151353 · Siemens Medical Solutions USA, Inc. · Aug 2015
GenIQ
K143368 · Ge Medical Systems, LLC · Jul 2015
3D/5D Viewer
K151808 · Samsung Medison Co., Ltd. · Jul 2015
Vitrea Software Toshiba Package, VSTP-001A
K151091 · Toshibamedical Systems Corporation · Jul 2015
syngo.via MI Workflows
K151192 · Siemens Medical Solutions USA, Inc. · Jun 2015
Ez3D-i/E3
K150761 · Ewoosoft Co., Ltd. · Jun 2015