NVA-63-8 Neurovascular Array Coil

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K020606 ↗

FDA Product Code

MOS

Device Class

Class II

Regulation

21 CFR Part 892.1000

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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• What is the NVA-63-8 Neurovascular Array Coil used for?

  The NVA-63-8 Neurovascular Array Coil is a radiofrequency (RF) receive-only coil designed specifically to improve the detection of magnetic resonance signals from the head and neck during MRI procedures. By enhancing signal clarity, it helps radiologists obtain sharper diagnostic images, which is particularly useful for evaluating neurovascular structures.

• Is the NVA-63-8 Neurovascular Array Coil sterile?

  No, the NVA-63-8 Neurovascular Array Coil is not sterile. It is supplied as a reusable device, meaning it must be cleaned, disinfected, and maintained according to established protocols to ensure proper functionality and patient safety between uses.

• How should the NVA-63-8 Neurovascular Array Coil be stored?

  The coil should be stored in a clean, dry environment, protected from physical damage and electromagnetic interference. Since it is reusable, it must be properly cleaned and stored in its original packaging or a designated storage case when not in use to maintain its integrity and performance.

• What regulatory approval does the NVA-63-8 Neurovascular Array Coil hold?

  The NVA-63-8 Neurovascular Array Coil has received FDA 510(k) clearance under K-number K020606. This clearance indicates that the device is considered substantially equivalent to a legally marketed predicate device and meets FDA requirements for safety and effectiveness in its intended use.

• Can the NVA-63-8 Neurovascular Array Coil be used with any MRI scanner?

  The coil is designed for use with MRI scanners in radiology settings, but compatibility depends on the specific MRI system’s technical specifications. While it is intended for general use in neurovascular imaging, users should verify compatibility with their MRI equipment to ensure optimal performance and safety.