# K143176: UltraLinq

- Pathway: 510(k) (Traditional)
- Applicant: Ultralinq Healthcare Solutions, Inc.
- Decided: Jul 17, 2015 after 255 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K935595 (1995). 86 ancestors in all.
No later device cites it as a predicate yet.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111694: ASTRA, Candelis, Inc. (2011) Summary page 4.
- K130779: Lvivo EF System, Diacardio, Ltd. (2013) Summary page 4.

## Indications for use
UltraLinq is a software image management system intended to receive, process, review, display, and archive medical images and data from imaging modalities (e.g. Ultrasound (US), and Magnetic Resonance (MR)). Images and data can be stored, communicated and displayed across computer systems and mobile devices. UltraLinq is a single system that can run on a web-enabled computer, iPad and iPhone and may be interfaced with other PACS systems. Diagnosis is not performed by the software but by qualified Physicians. Typical users of this system are trained and qualified professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants. UltraLinq is used to: • share reports and studies with other UltraLinq users, • review reports and studies, • download and save reports and studies, • send reports and studies to EMR and EHR systems, and • route reports and studies to other UltraLinq users. UltraLinq provides access to medical images on mobile devices for non-diagnostic viewing and referral purposes. The mobile device access functionality is used for patient management by the medical community in order to access and display patient data, medical reports, and medical images. Mobile devices are not intended to replace full diagnostic workstations and should be used only when there is no access to a workstation. 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 cardiac evaluation. This device is not to be used for mammography.

Source page: https://510kreport.com/device/K143176
Methodology: https://510kreport.com/methodology