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UltraLinq

ULTRALINQ HEALTHCARE SOLUTIONS, INC. · Model 58.13 · UDI-DI 00862894000302

LLZ Prescription

510(k) clearances

19,970

Adverse events (41 deaths)

561

Recalls

635

Facilities

Description

UltraLinq is a web-based software application that provides image processing and viewing tools and access to studies and reports from a web-enabled computer, iPad or iPhone. UltraLinq is intended for use by a physician or other trained medical professionals to receive, process, review, display and archive medical images and data from imaging modalities. Diagnosis is not performed by the software but by qualified Physicians. UltraLinq is also intended for non-invasive processing of already acquired echocardiographic images in order to detect, measure, and calculate the left ventricular wall for left ventricular function evaluation. This measurement, available on workstations only, can be used to assist the clinician in a cardiac evaluation. UltraLinq conforms to the ACR/NEMA DICOM 3.0 standard for interoperability with other DICOM compliant systems.

Recalls

Date	Firm	Reason
2026-09-05	INTELERAD MEDICAL SYSTEMS INCORPORATED	Following a Chromium-based web-browser, report and displayed images may not match.
2026-07-31	GE Healthcare	Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be
2026-07-31	GE Healthcare	Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be
2026-07-31	GE Healthcare	Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be
2026-07-31	GE Healthcare	Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be
2026-07-31	GE Healthcare	Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be
2026-07-31	GE Healthcare	Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be
2026-07-22	Merge Healthcare, Inc.	Software issue may cause measurements to be displayed inaccurately.
2026-07-22	FUJIFILM Healthcare Americas Corporation	Software issue may cause the ruler measurement to be inaccurate.
2026-06-30	Merge Healthcare, Inc.	Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.