The VuMAX HD Ophthalmic Ultrasound System is a non-invasive, active,device for imaging ocular features for diagnostic purposes.The B-scan mode ultilizes a sealed 12 MHz B-probe with a focused transducer. The system operates on a computer-based platform. B-scan settings include orbit, virtreous body, retina surface, and deep retina/choroid. The system includes the multi-frequency ultrasound system base unit, 22" LCD, 12 MHz B-probe, keyboard and mouse, USB foot switch, immersion cups and user manual.

The VuMAX HD Ophthalmic Ultrasound System is a non
VuMAX HD Ophthalmic Ultrasound System - VuMAX HD B Scan

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.

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Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: IYO

Device Name: System, Imaging, Pulsed Echo, Ultrasonic

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: RA

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 892.1560

Third Party Flag: Y

Medical Specialty: RA

Device Id: 00896100002187

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A