VuMAX HD Ophthalmic Ultrasound System

Basic Information

• Brand Name: VuMAX HD Ophthalmic Ultrasound System
• Primary DI: 00896100002194
• Version / Model: VuMAX-HD UBM
• Catalog Number: U.575
• Company Name: SONOMED, INC.
• Labeler DUNS: 107037079
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-10
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: fcd2393a-665f-4747-852e-4537f1cc4753

Device Description

The VuMAX HD Ophthalmic Ultrasound System is a non-invasive, active, bio-microscope (UBM) device for imaging ocular features for diagnostic purposes. It utilizes a 35 MHz and/or 50 MHz transducer with a sector scanning probe. B-scan settings include orbit, virtreous body, retina surface, and deep retina/choroid. UBM capabilities include sulcus-to-sulcus, angle detail, high resolution, and motion picture settings. The system includes the high frequency ultrasound system (UBM) including the base unit, 22" LCD, water-path probe, 35 MHz transducer, keyboard and mouse, USB foot switch, immersion cups and user manual.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	892.1560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11389	Ophthalmic ultrasound imaging system	An assembly of mains electricity (AC-powered) devices designed for ophthalmic imaging procedures. It includes software that supports a variety of static and real-time eye and orbital imaging applications including physical measurement and oncology related treatment. It will generate ultrasound pulses, direct them to a target area, detect the resulting ultrasound echoes, and process the resulting information producing and displaying static or dynamic two- or three-dimensional (3-D) images. This GMDN code includes ultrasound imaging systems with, e.g., A-mode, B-mode, Doppler, colour Doppler (CD), M-mode, and duplex (combination imaging, Doppler and/or colour flow) scanning capabilities.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00896100002194	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K060626	000