MicroConvex Array

GUDID 00860000784832

An invasive component of an ultrasound imaging assembly designed to be positioned within the vagina and/or rectum, either manually or under endoscopic guidance, for ultrasound imaging from within the vagina/rectum. Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to another device for display; it does not include an integrated display. It is intended for use with a dedicated ultrasound system with dedicated software installed. This is a reusable device.

LINKQUEST INC.

Rectal/vaginal ultrasound imaging transducer

• Primary Device ID: 00860000784832
• NIH Device Record Key: d4652692-4132-466b-b8b8-5e4f71b3431d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MicroConvex Array
• Version Model Number: LQ-E8C1
• 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: 8586239900
• 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	00860000784832 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172059

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

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: 2019-06-10 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: 2019-06-10An invasive component of an ultrasound imaging assembly designed to be positioned within the vagina and/or rectum, either manually or under endoscopic guidance, for ultrasound imaging from within the vagina/rectum. Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to another device for display; it does not include an integrated display. It is intended for use with a dedicated ultrasound system with dedicated software installed. This is a reusable device.
• 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