(121 days)
Prenuvo Body Composition is a software medical device (SaMD) which is intended for non-invasive fat, muscle and organ quantification. Designed to utilize DICOM-compliant magnetic-resonance image datasets acquired from compatible MR Systems, it displays the internal structure of the body, including the liver. Other physical parameters derived from the images may also be produced.
All reported metrics in the Body Composition Report are known in the practice of medicine.
Prenuvo Body Composition is indicated for individuals age 18 years and above.
Not Found
The provided document does not contain information about the acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is an FDA 510(k) clearance letter for the Prenuvo Body Composition device, stating that it has been found substantially equivalent to legally marketed predicate devices. It also lists the Indications for Use for the device.
To answer your request, I would need a different document that details the device's performance study and its pre-defined acceptance criteria.
§ 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.