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510(k) Data Aggregation
K Number
K173605Device Name
iQMR
Manufacturer
Date Cleared
2018-03-08
(107 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Medic Vision - Imaging Solutions Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The iQMR is intended for networking, communication, processing and enhancement of MRI images in DICOM format. The device processing is not effective for lesion, mass, or abnormalities of sizes less than 1.5mm. This device is indicated for use by qualified trained medical professionals.
Device Description
iQMR is a software package that is aimed to process MRI images. The iQMR processing enhances MRI images by reduction of the image noise. The software runs on a PC server, which is connected to the Local Area Network (LAN). The device receives MRI images from different work stations over the network in DICOM format, processes the images and transmits them in DICOM format, to selected work stations.
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