SONOMED, INC.

Address:1979 MARCUS AVE., SUITE C105,LAKE SUCCESS,NY,11042,US

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Device Description : The Master-Vu B-Scan Ophthalmic Ultrasound System is a non-invasive, active, dia The Master-Vu B-Scan Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biometric device intended for use in ophthalmic applications by imaging the internal structures of the eye. They system consists of a sealed, posterior segment B-probe and cable designed to interface with any standard personal computer (host PC). The probe utilizes a 12 MHz transducer with a sector scanning probe operating on the host PC. The software for the Master-Vu B-Scan allows the host PC to function as the main control interface and display for the B-scan system. The system is provided with the portable, hand-held B-probe with 12 MHz transducer, USB cable, Master-Vu B software on a flash drive, carry case and user manual.

Device Class : 2

Duns Number: 107037079

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

Device Description : The VuPad B-Scan Ophthalmic Ultrasound System is a non-invasive, active, diagnos The VuPad B-Scan Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biometric device intended for use in ophthalmic applications by imaging the internal structures of the eye.The VuPad B-Scan is a multi-purpose, computer-based,ultrasonic diagnostic system that produces a live, two-dimensional image to facilitate the identification and measurement of ocular pathologies in the posterior chamber of the eye. 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 system is provided with the portable B-Scan tablet, 12 MHz B-probe, built-in probe holder, foot switch and user manual.

Device Class : 2

Duns Number: 107037079

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

Device Description : The VuPad A/B-Scan Ophthalmic Ultrasound System is a non-invasive, active, diagn The VuPad A/B-Scan Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biometric device intended for use in ophthalmic applications.The system includes both A-Scan and B-Scan capabilities. The device is used by coupling the probe/transducer to the eye either by direct contact or immersion methods. The VuPad B-Scan mode produces a live, two-dimensional image to facilitate the identification and measurement of ocular pathologies in the posterior chamber of the eye. The A-Scan mode measures axial length (AXL), anterior chamber depth, and lens thickness and aids in the calculation of associated IOL power for implanted lenses. 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 system is provided with the portable A/B-scan tablet, 12 MHz B-probe, 10 MHz A-probe, built-in probe holders, foot switch and user manual.

Device Class : 2

Duns Number: 107037079

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

Device Description : The VuPad Ophthalmic Ultrasound System is a non-invasive, active, diagnostic, ul The VuPad Ophthalmic Ultrasound System is a non-invasive, active, diagnostic, ultrasound biomicroscopy device intended for use in ophthalmic applications.The ultrasound probe with the system is a water path probe with 35 MHz transducer providing high resolution images. The VuPad B-Scan mode produces a live, two-dimensional image to facilitate the identification and measurement of ocular pathologies in the posterior chamber of the eye. 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 system is provided with the portable UBM tablet, water-path probe with 35 MHz transducer, built-in probe holder, foot switch and user manual.

Device Class : 2

Duns Number: 107037079

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

Device Description : The VuPad Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and The VuPad Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biometric device intended for use in ophthalmic applications.The system includes capabilities for B-Scan and UBM (high frequency B-scan). The device is used by coupling the probe/transducer to the eye either by direct contact or immersion methods. The VuPad B-Scan mode produces a live, two-dimensional image to facilitate the identification and measurement of ocular pathologies in the posterior chamber of the eye. 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 system is provided with the portable B-Scan/UBM tablet, 12 MHz B-probe, water-path probe with 35 MHz transducer, built-in probe holders, foot switch and user manual.

Device Class : 2

Duns Number: 107037079

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

Device Description : The VuPad Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and The VuPad Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biometric device intended for use in ophthalmic applications.The system includes capabilities for A-Scan, B-Scan, and UBM (high frequency B-scan). The device is used by coupling the probe/transducer to the eye either by direct contact or immersion methods. The VuPad B-Scan mode produces a live, two-dimensional image to facilitate the identification and measurement of ocular pathologies in the posterior chamber of the eye. The A-Scan mode measures axial length (AXL), anterior chamber depth, and lens thickness and aids in the calculation of associated IOL power for implanted lenses. 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 system is provided with the portable A/B/UBM tablet, 12 MHz B-probe, 10 MHz A-probe, water-path probe with 35 MHz transducer, built-in probe holders, foot switch and user manual.

Device Class : 2

Duns Number: 107037079

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

Device Description : The VuPad A Ophthalmic Ultrasound System is a portable, ultrasound biometric rul 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.

Device Class : 2

Duns Number: 107037079

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

Device Description : The VuMAX HD Ophthalmic Ultrasound System is a non-invasive, active,device for 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.

Device Class : 2

Duns Number: 107037079

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

Device Description : The VuMAX HD Ophthalmic Ultrasound System is a non-invasive, active, bio-microsc 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 Class : 2

Duns Number: 107037079

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

Device Description : The VuMAX HD Ophthalmic Ultrasound System is a non-invasive, active, device for The VuMAX HD Ophthalmic Ultrasound System is a non-invasive, active, device for imaging ocular features for diagnostic purposes. It combines both A-scan and B-scan modes. The A-scan measures axial length (AXL), anterior chamber depth, lens thickness and vitreous length. 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, 10 MHz A-probe, keyboard and mouse, USB foot switch, and user manual.

Device Class : 2

Duns Number: 107037079

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1