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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-127-16-A Neurovascular Array Coil

This document is a 510(k) clearance letter from the FDA for a medical device called the "Model NVA-127-16-A Neurovascular Array Coil". This letter is NOT a study report and therefore does not contain information about acceptance criteria or a study proving that the device meets those criteria.

The information provided in the document focuses on:

• Device Name and Manufacturer: Invivo Corporation, Model NVA-127-16-A Neurovascular Array Coil
• Regulation Information: 21 CFR 892.1000, Magnetic resonance diagnostic device, Class II, Product Code: MOS
• Date of Clearance: October 12, 2005
• Substantial Equivalence: The FDA determined the device is substantially equivalent to legally marketed predicate devices.
• Indications for Use: "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."

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth, or expert qualifications as it is not present in the provided text.

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