MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)
ASG Superconductors S.P.A.MROpen Evo is a whole body MRI diagnostic device designed to produce high-resolution images of various body structures in multiple orientations, including brain examination with DWI sequence. It facilitates imaging for patients who might benefit from standing scans or have movement disorders, and incorporates advanced software features like Compressed Sensing for faster image acquisition. The device uses superconducting magnets cooled by a cryocooler and is intended for diagnostic imaging with certain limitations in cardiac, breast, lung, and upper abdominal imaging.
Intended Use
Whole body magnetic resonance diagnostic medical device intended for the production of images for diagnostic purposes with transverse, coronal, sagittal and oblique orientation relating to the internal structures of the examined body areas, also including the examination of the brain through the DWI sequence, with limitations regarding cardiac, breast, lung and upper abdominal imaging.
Technology
MROpen Evo consists of a magnetic unit, operator PC, electronic cabinet, penetration filters, coil sets, cushions, and the MR GUI-PRO 3.1 software. It employs an I-box 07 spectrometer with a separate server and a Leybold 5000i cryocooler to cool the superconducting cable. The device uses a compressed sensing reconstruction algorithm to speed MRI acquisition by subsampling k-space data, improving acquisition speed without compromising image quality.
Performance
Performance testing included non-clinical tests such as biocompatibility, electrical safety, EMC, software verification and validation, usability, acoustic noise, gradient output, SAR, dynamic forces on patient support, and comparison against predicate device performance. Testing demonstrated substantial equivalence to predicate device, safety, and effectiveness. Compressed Sensing reconstruction resulted in limited reconstruction errors and no artifacts, confirmed by software tests in accordance with IEC 62304.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/31/2024
3 months - 2
FDA Approval
11/26/2024
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