Address:7676 Woodbine Avenue,Markham Ontario,CA
Device Description : The ExactVu high resolution micro-ultrasound system is intended for use by quali The ExactVu high resolution micro-ultrasound system is intended for use by qualified medical professionals for diagnostic ultrasound imaging, data processing and guidance of puncture and biopsy. The ExactVu System is comprised of transducers responsible for ultrasound signal generation and recording, a needle guide and a main unit that controls the transducers, processes the acoustic data, and processes and displays images.
Device Class : 2
Duns Number: 203044268
Premarket Exempt : No
Prescription Use : No
Device Description : The ExactVu high resolution micro-ultrasound system is intended for use by quali The ExactVu high resolution micro-ultrasound system is intended for use by qualified medical professionals for diagnostic ultrasound imaging, data processing and guidance of puncture and biopsy. The ExactVu System is comprised of transducers responsible for ultrasound signal generation and recording, a needle guide and a main unit that controls the transducers, processes the acoustic data, and processes and displays images.
Device Class : 2
Duns Number: 203044268
Premarket Exempt : No
Prescription Use : No
Device Description : EV29L is a 29 MHz high resolution transrectal side-fire transducer.
Device Class : 2
Duns Number: 203044268
Premarket Exempt : No
Prescription Use : No
Device Description : EV9C is a transrectal end-fire transducer.
Device Class : 2
Duns Number: 203044268
Premarket Exempt : No
Prescription Use : No
Device Description : The EV29L Sterile Biopsy Needle Guide is a specially designed biopsy needle guid The EV29L Sterile Biopsy Needle Guide is a specially designed biopsy needle guide for use with the EV29L transducer.
Device Class :
Duns Number: 203044268
Premarket Exempt : No
Prescription Use : Yes
Device Description : The EV29L Reusable Needle Guide is a specially designed biopsy needle guide for The EV29L Reusable Needle Guide is a specially designed biopsy needle guide for use with the EV29L transducer.
Device Class : 2
Duns Number: 203044268
Premarket Exempt : No
Prescription Use : Yes
Device Description : EV5C is an abdominal end-fire transducer.
Device Class : 2
Duns Number: 203044268
Premarket Exempt : No
Prescription Use : No
Device Description : Sterile transperineal needle guide with sheath for use with the EV29L transducer.
Device Class :
Duns Number: 203044268
Premarket Exempt : No
Prescription Use : Yes
Device Description : Non-Sterile Reusable Transrectal Needle Guide for use with the Exact Imaging EV2 Non-Sterile Reusable Transrectal Needle Guide for use with the Exact Imaging EV29L Transducer
Device Class : 2
Duns Number: 203044268
Premarket Exempt : No
Prescription Use : Yes
Device Description : Sterile transrectal needle guide with sheath for use with the Exact Imaging EV29 Sterile transrectal needle guide with sheath for use with the Exact Imaging EV29L Transducer
Device Class :
Duns Number: 203044268
Premarket Exempt : No
Prescription Use : Yes