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510(k) Data Aggregation
K Number
K974535Device Name
DISCAM DIGITAL IMAGING SYSTEM
Manufacturer
MARCHER ENTERPRISES, LTD.
Date Cleared
1998-08-14
(255 days)
Product Code
HKI
Regulation Number
886.1120Why did this record match?
Applicant Name (Manufacturer) :
MARCHER ENTERPRISES, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Discam® Digital Imaging System is intended to be used as an ophthalmic diagnostic tool, which is complimentary to other accepted diagnostic technologies, to track the progress of glaucoma, relative to monitoring changes in the appearance (size and shape) of the Optic Disc.
The Discam® Digital Imaging System is intended to be used to evaluate the Optic Disc, (Optic Nerve Head). It is used in the same fashion as a Fundus camera, except that it's field of view is narrower, in order to focus exclusively on the Optic Disc, (Optic Nerve Head). Evaluation of changes in the size and shape of the Optic Disc, (Optic Nerve Head), is useful in monitoring the progress of patients with Ocular Hypertension, and Glaucoma.
Device Description
The Discam® Digital Imaging System consists of a CCD Stereo Camera that captures stereo images through an image capture board interfaced with a PC with the minimum requirements mages arough an RAM, 1 GB Hard Disc, 133 MHz CPU, Windows® 95 OS. The CCD stereo camera and housing is mounted on a standard rise and fall table, along with a standard adjustable patient chin rest.
The patient fixates on fixation lights, (fixed LEDs), and the operator views the image on the PC's monitor. Image capture, which is accomplished in 0.2 seconds, is initiated by pushing a iov stick.
Windows® based software allows basic analysis, (measurement of cup and Disc, cup to Disc ratio), of the captured images, using either our optional analysis software, or third party software with user developed algorithms, and data archiving.
The camera measures 370 mm Depth x 360 mm Height x 108 mm Width. It is powered by a switch mode power supply 100 V to 220 V, 50 Hz to 60 Hz.
Illumination is from a 12 Volt 55 Watt Halogen Lamp. There is no flash.
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