LinkQuest Diagnostic Ultrasound System and Transducers

GUDID 00860000784801

A devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is a mobile assembly which support a wide variety of transducers and related application software packages.

LINKQUEST INC.

General-purpose ultrasound imaging system

• Primary Device ID: 00860000784801
• NIH Device Record Key: d8cd2959-adeb-4a4a-844e-8646b55bb1c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LinkQuest Diagnostic Ultrasound System and Transducers
• Version Model Number: Model SQ860
• Company DUNS: 144772626
• Company Name: LINKQUEST 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: 1858623-9900
• Email: sales@link-quest.com

Operating and Storage Conditions

• Handling Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860000784801 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172059

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, Ultrasonic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-10
• Device Publish Date: 2019-06-01

Devices Manufactured by LINKQUEST INC.

• 00860000784801 - LinkQuest Diagnostic Ultrasound System and Transducers: 2019-06-10A devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is a mobile assembly which support a wide variety of transducers and related application software packages.
• 00860000784801 - LinkQuest Diagnostic Ultrasound System and Transducers: 2019-06-10 A devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (
• 00860000784818 - Linear Array: 2019-06-10 A hand-held noninvasive component of an ultrasound imaging assembly designed to be moved over the intact surface of a patient's
• 00860000784825 - Convex Array: 2019-06-10 A hand-held noninvasive component of an ultrasound imaging assembly designed to be moved over the intact surface of a patient's
• 00860000784832 - MicroConvex Array: 2019-06-10 An invasive component of an ultrasound imaging assembly designed to be positioned within the vagina and/or rectum, either manual
• 00860000784849 - Phase Array: 2019-06-10 A hand-held noninvasive component of an ultrasound imaging assembly designed to be moved over the intact surface of a patient's
• 00860000784856 - Convex 3D Array: 2019-06-10 A hand-held noninvasive component of an ultrasound imaging assembly designed to be moved over the intact surface of a patient's