(175 days)
The MROpen is a total body magnetic resonance imaging device, It is indicated for use as a diagnostic total body imaging device that produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the body. The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The MR parameters that determine image appearance are proton density, spin-lattice relaxation time (T), spin-spin relaxation time (T2), chemical shift and flow velocity. When interpreted by a trained physician, these images can yield information that can be useful in the determination of a diagnosis.
The MROpen is a total body magnetic resonance imaging device
I am sorry, but the provided text does not contain the detailed information necessary to answer your request regarding acceptance criteria, device performance, study details, expert qualifications, adjudication methods, or the use of AI in a comparative effectiveness study.
The document is a 510(k) premarket notification letter from the FDA to Paramed Srl concerning their "MrOpen" Magnetic Resonance diagnostic device. It confirms the device's substantial equivalence to legally marketed predicate devices and outlines regulatory requirements.
Specifically, the text is a formal communication acknowledging the filing and approval of the 510(k) and provides the "Indications For Use" for the MrOpen device. It does not include any technical data, study results, or performance metrics that would be necessary to populate the table or answer the specific questions about acceptance criteria and how they were met.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.