UltraLinq

GUDID 00862894000302

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.

ULTRALINQ HEALTHCARE SOLUTIONS, INC.

Multidisciplinary medical image management software

• Primary Device ID: 00862894000302
• NIH Device Record Key: 5a009680-28c4-4384-9b96-ef36923bbac2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UltraLinq
• Version Model Number: 58.13
• Company DUNS: 830536756
• Company Name: ULTRALINQ HEALTHCARE SOLUTIONS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-227-2956
• Email: support@ultralinq.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00862894000302 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143176

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-09-24
• Device Publish Date: 2016-09-24

Devices Manufactured by ULTRALINQ HEALTHCARE SOLUTIONS, INC.

• 00862894000319 - UpLinq: 2021-06-10 Client site located software application that receives IAD-generated data and provides the mechanism by which patient informatio
• 00862894000302 - UltraLinq: 2018-09-24UltraLinq 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.
• 00862894000302 - UltraLinq: 2018-09-24 UltraLinq is a web-based software application that provides image processing and viewing tools and access to studies and reports