(85 days)
The 1.5T Extremity Array is a four-coil phased array device which operates in the transmit-receive mode. The device is intended to excite and receive signal from hydrogen protons for diagnostic quelity radiographic images when used with GE 1.5T Signa Advantage, Horizon and Horizon LX scanner(s) during MR imaging.
The 1.5T Extremity Array is a four-coil phased array device which operates in the transmit-receive mode.
I am sorry, but the provided text does not contain information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, details of comparative effectiveness studies (MRMC), standalone performance, or training set information.
The document is a 510(k) clearance letter from the FDA for a medical device (MEDRAD 1.5T Extremity Array) and specifies its intended use and regulatory classification. It does not include the technical study details typically found in a clinical study report or a detailed submission document that would outline performance metrics and their validation.
§ 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.