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510(k) Data Aggregation
K Number
K062295Device Name
IRI INTEGRATED RETINAL IMAGER
Manufacturer
MEDIVISION MEDICAL IMAGING, LTD.
Date Cleared
2006-10-20
(74 days)
Product Code
HKI
Regulation Number
886.1120Why did this record match?
Applicant Name (Manufacturer) :
MEDIVISION MEDICAL IMAGING, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IRI™ Integrated Retinal Imager System is a monocular retinal imager designed for routine use. The imager is suitable for documentation of findings in a clinical setting.
Device Description
Medivision's IRI™ Integrated Retinal Imager System is a retinal camera, which is designed to perform digital fundus imaging. IRI™, as other fundus cameras, uses light photography to obtain clinical information. Using light sources (LEDs of different colours, a set of lenses and filters, and digital camera sensors, an image from the eye's retina is captured and later displayed for review. The device comprises a main console, a PC, a touch screen (as part of the main console) and a monitor. Digital image storage is available to several storage media.
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K Number
K953974Device Name
CAMVISION 1000
Manufacturer
MEDIVISION MEDICAL IMAGING, LTD.
Date Cleared
1996-09-09
(383 days)
Product Code
JAA
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
MEDIVISION MEDICAL IMAGING, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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