iQMR is a software package designed to enhance MRI images by reducing noise and improving image quality. It operates on a PC server connected to a network, receiving and transmitting MRI images in DICOM format. This helps medical professionals get clearer images for better diagnosis and analysis.
Intended Use
Networking, communication, processing and enhancement of MRI images in DICOM format. Not effective for lesions, masses, or abnormalities smaller than 1.5mm. Intended for use by qualified medical professionals.
Technology
iQMR is a software package installed on an off-the-shelf PC server running Linux Ubuntu, consisting of user interface, algorithm, and interface modules, processing MRI images in DICOM format using Medic Vision's proprietary algorithms.
Performance
The device software was verified using a predefined software test plan. Performance was validated using MRI standard phantoms and clinical MRI images in an end-user environment, demonstrating that the device meets its design input and intended use requirements. No clinical trials were conducted.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/21/2017
3 months - 2
FDA Approval
3/8/2018
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