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8000-INS-UMENG Rev. 4
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General Device Description
The DGH 8000 is a diagnostic ultrasound device used by professionals in the
ophthalmic field to produce cross-sectional images of the eye and orbit. The probe is
comprised of a 12 MHz, single element transducer that is mechanically oscillated to
perform a 60-degree sector scan of the eye. The probe hand piece contains the
electronics used to pulse the transducer as well as to measure, filter and amplify the
resulting echoes from intraocular and orbital tissue. The probe is powered and controlled
via a USB 2.0 cable, which must be connected to a PC or Laptop running the Scanmate
software. The Scanmate software interprets the digital signals transmitted by the probe
and displays a “Brightness Scan” that shows the relative magnitude of the echo spikes
received by the transducer. The software allows the user to adjust the scan rate of the
probe (12 or 15 MHz) as well as the gain, contrast, intensity, and depth of the displayed
image. Once the exam is complete, the application allows the user to save video(s),
image(s) or create a report to document the results.
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Device Classification
Device: System, Imaging, Pulsed Echo, Ultrasonic
Panel: Radiology
Product Code: IYO
Device Class: II
Regulation Number: 21 CFR 892.1560
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Indications for Use
The DGH 8000 Scanmate-B is an ultrasonic device used by professionals in the
ophthalmic field to perform a “Brightness Scan” of the eye. The main function of the
device is to produce cross-sectional images of the eye and orbit and to serve as an aid in
the detection and assessment of physical and functional abnormalities using established
diagnostic criteria.
