(12 days)
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the head and neck, that can be interpreted by a trained physician.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a Magnetic Resonance Diagnostic Device (NVA-63-8-A and NVA-63-16-A Neurovascular Array Coil). This document does not contain information about acceptance criteria, device performance results, specific study details, or comparative effectiveness studies.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." This means the FDA found the device to be similar enough to existing, approved devices that it doesn't require a new, full pre-market approval application (PMA). Substantial equivalence is often established by comparing the new device's technological characteristics and performance to a predicate device, but the details of those specific tests and their acceptance criteria are not included in this letter.
Therefore, I cannot fulfill your request for the tables and study details based solely on the provided text. The document is an FDA clearance letter, not a detailed technical report or clinical study summary.
To answer your questions, I would need a different type of document, such as:
- A clinical study report
- A section of the 510(k) submission that details the performance data and testing methods
- A summary of regulatory compliance testing
Without such information, any attempt to provide the requested details would be speculative and inaccurate.
§ 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.