(134 days)
MAGNETOM Amira is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used.
These images and or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
MAGNETOM Amira may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.
MAGNETOM Amira (1.5T) is an MRI svstem that is substantially equivalent to the previously cleared primary predicate device MAGNETOM Aera (K141977, cleared November 19, 2014) and secondary predicate device MAGNETOM ESSENZA (K130262, cleared Mach 1, 2013).
The MAGNETOM Amira utilizes a superconducting magnet design. The open bore, whole body scanners are designed for increased patient comfort. They focus on ergonomics and usability to simplify the MR workflow.
The MAGNETOM Amira systems will be available in a fixed configuration.
This document describes the FDA 510(k) clearance for the Siemens MAGNETOM Amira with Software syngo MR E11, a magnetic resonance diagnostic device (MRDD). It does not contain information about acceptance criteria for an AI/ML powered device, nor does it detail a study proving such a device meets acceptance criteria.
The document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices (MAGNETOM Aera and MAGNETOM ESSENZA) based on its intended use and technological characteristics, not on the performance of an AI-powered component.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, or MRMC studies related to an AI component, as this information is not present in the provided text.
The information provided pertains to the device itself (MAGNETOM Amira) as a magnetic resonance diagnostic device, and not to an AI/ML algorithm within or associated with it.
§ 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.