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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.

Model NVA-63-8 Neurovascular Array Coil

This document is an FDA 510(k) clearance letter for a medical device called the "NVA-63-8 Neurovascular Array Coil." It primarily focuses on the regulatory aspects of the device and confirms its substantial equivalence to a predicate device.

Crucially, this document does not contain information about specific acceptance criteria, a study that proves the device meets those criteria, or the detailed aspects of a study (like sample sizes, ground truth establishment, or expert qualifications).

The letter states the "Indications for use:" are: "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." This is a general statement about its intended function, not performance metrics.

Therefore, I cannot provide the requested information based solely on the provided text. The document is a regulatory approval, not a scientific study report.

To answer your request, I would need a different document, such as a summary of safety and effectiveness data (SSED) that would have been part of the original 510(k) submission, or a published study related to the device's performance.

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