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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 SOPIX series digital X-ray imaging systems are intended to be used by a dental practitioner. The sensor (located in the patient’s mouth just like a silver fi lm) captures the X-rays produced by the generator. Then it transmits this data to the computer to display the X-ray image on the screen. All the images captured with the SOPIX series system can be recalled onto the screen with the Sopro Imaging software provided with the system. This software manages the display, processing and storage of images taken with the SOPIX series system. A.C.E™ (Automatic Control Exposure) technology, patented by SOPRO, provides the system with outstanding features. In real time it analyses the quantity of energy received by the sensor, which fi xes the image acquisition once it has received the energy needed to produce a good-quality image. As a result, every image is protected against overexposure."
SOPRO
CAPT SOPIX² T2 USB2 CONDO
In Commercial Distribution

  • M430S80200051 ()
S_802_0005

  • Dental digital imaging sensor, intraoral
The g.HIamp is intended to be used for measuring, recording and analysing of electrical activity of the brain and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for EEG. It captures the data, converts it into digital form and passes it on to a host computer running appropriate software. The device can be used for adults, children, infants and animals.
g.tec medical engineering GmbH
16-Channel Amplifier
In Commercial Distribution

  • EBCI7092US0 ()

  • Channel Number 16
7092US

  • Multiple physiological signal amplifier
The g.HIamp is intended to be used for measuring, recording and analysing of electrical activity of the brain and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for EEG. It captures the data, converts it into digital form and passes it on to a host computer running appropriate software. The device can be used for adults, children, infants and animals.
g.tec medical engineering GmbH
32-Channel Amplifier
In Commercial Distribution

  • EBCI7091US0 ()

  • Channel Number 16
7091US

  • Multiple physiological signal amplifier
The g.HIamp is intended to be used for measuring, recording and analysing of electrical activity of the brain and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for EEG. It captures the data, converts it into digital form and passes it on to a host computer running appropriate software. The device can be used for adults, children, infants and animals.
g.tec medical engineering GmbH
256-Channel Amplifier
In Commercial Distribution


  • Channel Number 256
7003

  • Multiple physiological signal amplifier
The g.HIamp is intended to be used for measuring, recording and analysing of electrical activity of the brain and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for EEG. It captures the data, converts it into digital form and passes it on to a host computer running appropriate software. The device can be used for adults, children, infants and animals.
g.tec medical engineering GmbH
256-Channel Amplifier
Not in Commercial Distribution

  • EBCI70030 ()

  • Channel Number 256
7003

  • Multiple physiological signal amplifier
The g.HIamp is intended to be used for measuring, recording and analysing of electrical activity of the brain and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for EEG. It captures the data, converts it into digital form and passes it on to a host computer running appropriate software. The device can be used for adults, children, infants and animals.
g.tec medical engineering GmbH
144-Channel Amplifier
In Commercial Distribution


  • Channel Number 144
7002

  • Multiple physiological signal amplifier
The g.HIamp is intended to be used for measuring, recording and analysing of electrical activity of the brain and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for EEG. It captures the data, converts it into digital form and passes it on to a host computer running appropriate software. The device can be used for adults, children, infants and animals.
g.tec medical engineering GmbH
144-Channel Amplifier
Not in Commercial Distribution

  • EBCI70020 ()

  • Channel Number 144
7002

  • Multiple physiological signal amplifier
The g.HIamp is intended to be used for measuring, recording and analysing of electrical activity of the brain and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for EEG. It captures the data, converts it into digital form and passes it on to a host computer running appropriate software. The device can be used for adults, children, infants and animals.
g.tec medical engineering GmbH
80-Channel Amplifier
In Commercial Distribution


  • Channel Number 80
7001

  • Multiple physiological signal amplifier
The g.HIamp is intended to be used for measuring, recording and analysing of electrical activity of the brain and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for EEG. It captures the data, converts it into digital form and passes it on to a host computer running appropriate software. The device can be used for adults, children, infants and animals.
g.tec medical engineering GmbH
80-Channel Amplifier
Not in Commercial Distribution

  • EBCI70010 ()

  • Channel Number 80
7001

  • Multiple physiological signal amplifier
The Varia Transcranial Doppler Ultrasound (TCD) device provides precision measurements of cerebrovascular blood flow. Designed to exacting standards, Varia delivers excellent signal quality with minimal ambient noise, allowing clinicians to easily locate vessels and obtain high-quality measurements. When attached to an external MS Windows-based computer, Varia presents the clinician with an intuitive interface including clear displays and easy-to-use input parameters to facilitate a quality exam. Utilized with software only device accessory Varia-NCI.
NEUROCHAOS SOLUTIONS INC
1
In Commercial Distribution

  • B41278000 ()
7800

  • Noninvasive vascular ultrasound system, line-powered
  • Invasive vascular ultrasound system
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