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510(k) Data Aggregation
K Number
K990205Device Name
DIGISCOPE OPHTHALMIC CAMERA
Manufacturer
Date Cleared
1999-03-26
(64 days)
Product Code
Regulation Number
886.1120Why did this record match?
Applicant Name (Manufacturer) :
EYE TEL IMAGING, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Digiscope is an automated imaging device of the fundus that is intended to capture, store, and transmit images of the fundus using lossless compression to a distant location for display. The Digiscope requires minimal operator training and intervention during the imaging process. It is indicated for individuals where examination of the fundus for pathologies is requested.
Device Description
The Digiscope Ophthalmic camera consists of: (1) a video camera; (2) an imaging system: (3) a computer with image acquisition and hardware control capabilities; (4) a monitor; and (5) EyeTel's Digiscope software. The Digiscope is intended to capture, store, and transmit images of the fundus and is indicated for use as an ophthalmic camera for individuals where examination of the fundus for pathologies is requested. The images of the fundus are digitized, stored on the Digiscope's hard drive, and transmitted via lossless compression for display at distant locations.
The Digiscope's user/software interface allows the images of the eye to be acquired, monitored, stored, and retrieved. Data is input into the Digiscope software via a touchscreen. Imaging, focusing, and camera orientation in relation to the retina are controlled by the software with verification and monitoring by the user. The software allows the user to monitor the image capture process and verify that the device is operating appropriately.
The image of the fundus is acquired by the Digiscope and stored in individual image data files in an uncompressed state on the hard drive of the computer system and displayed electronically. The images may then be transmitted via lossless compression to distant locations for display using a modem and standard telecommunications connections.
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