Device Description : A devices designed to collect, display, and analyse ultrasound images during a v A devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is a mobile assembly which support a wide variety of transducers and related application software packages.
Device Class : 2
Duns Number: 144772626
Premarket Exempt : No
Prescription Use : Yes
Device Description : A hand-held noninvasive component of an ultrasound imaging assembly designed to A hand-held noninvasive component of an ultrasound imaging assembly designed to be moved over the intact surface of a patient's body, typically with a coupling gel, during a variety of extracorporeal ultrasound imaging procedures (non-dedicated). Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to an ultrasound system controller for image processing and display. This is a reusable device.
Device Class : 2
Duns Number: 144772626
Premarket Exempt : No
Prescription Use : Yes
Device Description : A hand-held noninvasive component of an ultrasound imaging assembly designed to A hand-held noninvasive component of an ultrasound imaging assembly designed to be moved over the intact surface of a patient's body, typically with a coupling gel, during a variety of extracorporeal ultrasound imaging procedures (non-dedicated). Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to an ultrasound system controller for image processing and display. This is a reusable device.
Device Class : 2
Duns Number: 144772626
Premarket Exempt : No
Prescription Use : Yes
Device Description : An invasive component of an ultrasound imaging assembly designed to be positione An invasive component of an ultrasound imaging assembly designed to be positioned within the vagina and/or rectum, either manually or under endoscopic guidance, for ultrasound imaging from within the vagina/rectum. Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to another device for display; it does not include an integrated display. It is intended for use with a dedicated ultrasound system with dedicated software installed. This is a reusable device.
Device Class : 2
Duns Number: 144772626
Premarket Exempt : No
Prescription Use : Yes
Device Description : A hand-held noninvasive component of an ultrasound imaging assembly designed to A hand-held noninvasive component of an ultrasound imaging assembly designed to be moved over the intact surface of a patient's body, typically with a coupling gel, during a variety of extracorporeal ultrasound imaging procedures (non-dedicated). Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to an ultrasound system controller for image processing and display. This is a reusable device.
Device Class : 2
Duns Number: 144772626
Premarket Exempt : No
Prescription Use : Yes
Device Description : A hand-held noninvasive component of an ultrasound imaging assembly designed to A hand-held noninvasive component of an ultrasound imaging assembly designed to be moved over the intact surface of a patient's body, typically with a coupling gel, during a variety of extracorporeal ultrasound imaging procedures (non-dedicated). Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to an ultrasound system controller for image processing and display. This is a reusable device.
Device Class : 2
Duns Number: 144772626
Premarket Exempt : No
Prescription Use : Yes