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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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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.
SONOMED, INC.
VuMAX HD B Scan
In Commercial Distribution

  • 00896100002187 ()
B.575

  • Ophthalmic ultrasound imaging system
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.
VuPad A
In Commercial Distribution

  • 00896100002170 ()
A.580

  • Ophthalmic ultrasound imaging system
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.
SONOMED, INC.
VuPad A/B/UBM
In Commercial Distribution

  • 00896100002163 ()
BUA.580

  • Ophthalmic ultrasound imaging system
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.
SONOMED, INC.
VuPad B/UBM
In Commercial Distribution

  • 00896100002156 ()
BU.580

  • Ophthalmic ultrasound imaging system
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.
SONOMED, INC.
VuPad UBM
In Commercial Distribution

  • 00896100002149 ()
U.580

  • Ophthalmic ultrasound imaging system
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.
SONOMED, INC.
VuPad A/B
In Commercial Distribution

  • 00896100002132 ()
BA.580

  • Ophthalmic ultrasound imaging system
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.
SONOMED, INC.
VuPad B
In Commercial Distribution

  • 00896100002125 ()
B.580

  • Ophthalmic ultrasound imaging system
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.
SONOMED, INC.
MV5600
In Commercial Distribution

  • 00896100002118 ()
MV5600

  • Ophthalmic ultrasound imaging system
The Master-Vu A-Scan Ophthalmic Ultrasound System 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 Master-Vu A-Scan can be used to collect scan data using the direct contact or immersion method. There are five examination modes: Cataract, Dense Cataract, Aphakic, Pseudophakic and 4-Gate Manual. The Master-Vu A-Scan system includes the A-Scan console, a 10 MHz A-probe, foot switch, flash drive with A-scan software, USB cable, carry case and operator manual.
SONOMED, INC.
MV4500
In Commercial Distribution

  • 00896100002101 ()
MV4500

  • Ophthalmic ultrasound imaging system
The PacScan 300 Plus ophthalmic ultrasound system is a non-invasive, active device intended for imaging ocular features for diagnostic purposes. The system integrates A-Scan and Pachymeter capabilities into a single system. 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 pachymeter is a biometric device that allows for measuring and mapping corneal thickness. The 300A+ A-Scan model can be used to collect scan data using the direct contact or immersion method. There are five examination modes: Cataract, Dense Cataract, Aphakic, Pseudophakic and 4-Gate Manual. The pachymeter uses a higher frequency signal to measure shorter distances. The PacScan 300AP+ system includes a 6" color LCD, touch screen, built-in thermal printer, 10 MHz A-probe, 20 MHz Pachymeter probe, foot switch and operator manual.
SONOMED, INC.
300AP+ A-Scan/Pachymeter
In Commercial Distribution

  • 00896100002095 ()
300AP+

  • Ophthalmic ultrasound imaging system
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