HAC-420 Head Array Coil

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

510(k) Number

K013322 ↗

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 HAC-420 Head Array Coil used for?

  The HAC-420 Head Array Coil is a radiofrequency receiver coil designed specifically for Magnetic Resonance Imaging (MRI) systems. It improves signal detection from the head region, which enhances image quality and diagnostic accuracy in radiology applications. By focusing on the head, it helps radiologists obtain clearer and more detailed images for better patient evaluation.

• Is the HAC-420 Head Array Coil single-use or reusable?

  The HAC-420 Head Array Coil is a reusable device. It is intended for repeated use in MRI environments, provided it undergoes proper handling, storage, and maintenance. Regular upkeep ensures its functionality and maintains patient safety during MRI procedures.

• What safety standards must the HAC-420 Head Array Coil comply with?

  The HAC-420 Head Array Coil must comply with MRI safety standards to ensure safe operation within MRI environments. As a reusable device, it requires adherence to these standards to prevent risks such as interference or patient injury. Proper maintenance and usage protocols are critical to uphold these safety requirements.

• How is the HAC-420 Head Array Coil supplied, and what are its key specifications?

  The HAC-420 Head Array Coil is supplied as a reusable accessory for MRI systems. It is classified under FDA regulation 892.1000 and is cleared under FDA 510(k) K013322 as substantially equivalent to a predicate device. The coil is designed to enhance imaging quality for head scans and is intended for use in radiology applications.

• What regulatory approval does the HAC-420 Head Array Coil hold?

  The HAC-420 Head Array Coil holds FDA 510(k) clearance (K013322) with a decision date of October 16, 2001. This clearance indicates that the device is deemed substantially equivalent to a predicate device and meets the necessary regulatory requirements for use in MRI procedures. The approval is specific to its intended use as a specialty coil for head imaging.