VuPad Ophthalmic Ultrasound System A.580

GUDID 00896100002170

The VuPad A Ophthalmic Ultrasound System is a portable, ultrasound biometric ruler that is a non-invasive, active device intended for imaging ocular features for diagnostic purposes. The A-Scan system allows for measuring the axial length (AXL), anterior chamber depth, and lens thickness of an eye and for calculating the associated IOL power for an implanted lens. The VuPad A-Scan is used by coupling the probe/transducer to the eye either through direct contact or by immersion method with scan mode capabilities for cataract, dense cataract, aphakic, and pseudophakic. The system is a stand-alone system that runs on a Windows 10 platform and may be networked for interface with electronic medical records systems and printers. The VuPad A-Scan system includes the portable A-Scan tablet, a 10 MHz A-probe, built-in probe holder, foot switch and operator manual.

SONOMED, INC.

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• Primary Device ID: 00896100002170
• NIH Device Record Key: 0adfd437-1365-4d95-8a00-968f3a1036e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VuPad Ophthalmic Ultrasound System
• Version Model Number: VuPad A
• Catalog Number: A.580
• Company DUNS: 107037079
• Company Name: SONOMED, 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: true
• Serial Number: true
• Manufacturing Date: true
• 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: 800-227-1285
• Email: info@sonomedinc.com
• Phone: 800-227-1285
• Email: info@sonomedinc.com
• Phone: 800-227-1285
• Email: info@sonomedinc.com
• Phone: 800-227-1285
• Email: info@sonomedinc.com
• Phone: 800-227-1285
• Email: info@sonomedinc.com
• Phone: 800-227-1285
• Email: info@sonomedinc.com
• Phone: 800-227-1285
• Email: info@sonomedinc.com
• Phone: 800-227-1285
• Email: info@sonomedinc.com
• Phone: 800-227-1285
• Email: info@sonomedinc.com
• Phone: 800-227-1285
• Email: info@sonomedinc.com
• Phone: 800-227-1285
• Email: info@sonomedinc.com
• Phone: 800-227-1285
• Email: info@sonomedinc.com
• Phone: 800-227-1285
• Email: info@sonomedinc.com
• Phone: 800-227-1285
• Email: info@sonomedinc.com
• Phone: 800-227-1285
• Email: info@sonomedinc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00896100002170 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140199

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-06-23
• Device Publish Date: 2016-08-10

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