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510(k) Data Aggregation
K Number
K141061Device Name
REMOTEYE VIEWER
Manufacturer
Date Cleared
2014-08-01
(99 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
NEOLOGICA S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The RemotEye Viewer software product is intended to be used as a fully functional, web-based medical image viewer to download, review, interpret, manipulate, visualize and print medical multi-modality image data in DICOM format, also stored in remote locations with respect to the viewing site. When interpreted by a trained physician, the medical images displayed by RemotEye Viewer can be used as an element for diagnosis.
Typical users of RemotEye Viewer are trained professionals, including but not limited to radiologists, physicians, nurses and technicians.
Device Description
The RemotEye Viewer software product is a feature-rich, diagnostic-level, web-based DICOM medical image viewer that allows downloading, reviewing, interpreting, manipulating, visualizing and printing medical multi-modality image data in DICOM format, from a client machine. The DICOM images may be physically remote with respect to the viewing client, but reachable through a network.
Typical users of RemotEye Viewer are trained professionals, including but not limited to radiologists, physicians, nurses and technicians.
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