(29 days)
The Altaire MR system is an imaging device, and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.
The ALTAIRE is a Magnetic Resonance Imaging System that utilizes a 0.7 Tesla superconducting magnet in an open gantry. The design was based on the AIRIS II Open MRI system. This system takes advantage of the imaging properties of the 0.7T magnet.
The provided 510(k) summary for the ALTAIRE Magnetic Resonance Imaging System w/V5.0 Operating System Software (K050602) does not contain any information regarding acceptance criteria, device performance metrics, or study details.
The document primarily focuses on:
- Device Identification: Submitter information, device names, and predicate device.
- Intended Use: Standard description of an MRI system's diagnostic purpose.
- Device Description: Technical details about the 0.7 Tesla MRI system, its scientific principles (MRI physics), and its physical/performance characteristics (high-quality anatomical images without ionizing radiation, various image contrasts).
- Technological Characteristics: States similarity to a predicate device with software enhancements.
- Conclusions: Declares substantial equivalence to the predicate device.
- FDA Approval Letter: Confirms substantial equivalence based on the provided information.
- Indications for Use: Reiterates the standard clinical applications for an MRI system for various anatomical regions and imaging techniques.
Therefore, I cannot provide a table of acceptance criteria, reported device performance, or details about a study proving the device meets acceptance criteria, as this information is not present in the provided text.
In summary, the input text does not contain the information requested in your prompt regarding acceptance criteria and performance studies.
§ 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.