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510(k) Data Aggregation
K Number
K082196Device Name
STATIC VESSEL ANALYZER
Manufacturer
Date Cleared
2009-06-16
(316 days)
Regulation Number
886.1120Why did this record match?
Applicant Name (Manufacturer) :
IMEDOS GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Static Vessel Analyzer (SVA) with VesselMap2 is intended to capture, display, store, and manipulate images of the eye, especially the retina area, as well as surrounding areas, to aid in diagnosing or monitoring diseases of the eye that may be observed and photographed. Specifically, the VesselMap2 software is intended to be used for semiautomated measurement and calculation of the retinal artery/vein diameter ratio.
Device Description
The IMEDOS SVA unit is designed as a complete Fundus Imaging system or the software can be sold separately as a standalone product. The SVA software consist of two components - VisualIS, an imaging software for capture, display, storage and manipulation of images of the eye and VesselMap2, an add-on for enhanced analysis of retina images. VisualIS captures the images which are provided by the fundus camera and the connected digital image sensor. Together with an image set the data of the patient are recorded and stored. The complete examination can be stored and opened for follow-up examination purposes. The add-on VesselMap2 offers a semi-automated measurement for Arterial -- Venous Ratio of retinal vessels. The software allows the user to select veins and arteries. Vessel diameters are estimated by the software and the ratio of the analyzed arteries to veins is calculated. The image is not altered in any way during this calculation.
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