HNC-127-TRIO Neurovascular Array Coil

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

510(k) Number

K021570 ↗

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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See all devices from Mri Devices Corp. →

• What is the HNC-127-TRIO Neurovascular Array Coil used for?

  The HNC-127-TRIO Neurovascular Array Coil is a Class II magnetic resonance imaging coil designed to receive radiofrequency signals from patient anatomy in the head and neck during MR imaging procedures. It transforms these signals into raw data that is used by the scanner to reconstruct diagnostic images for clinical radiology settings.

• How is the HNC-127-TRIO Neurovascular Array Coil supplied and is it single-use or reusable?

  The device is operated by trained MR technologists or radiologists in radiology departments. The device data does not specify whether it is single-use or reusable, nor does it provide information about packaging or supply details beyond its intended use with MRI scanners in clinical settings.

• What is the regulatory status of the HNC-127-TRIO Neurovascular Array Coil?

  The HNC-127-TRIO Neurovascular Array Coil is authorized under FDA 510(k) clearance with K-number K021570, received on May 14, 2002, and decided on June 12, 2002. It is classified as a Class II device and manufactured by MRI Devices Corp. The clearance type is Special and it was determined to be substantially equivalent.

• Are there different sizes or models of the HNC-127-TRIO Neurovascular Array Coil available?

  The device data does not specify different sizes or models of the HNC-127-TRIO Neurovascular Array Coil. The information provided only references this specific model number and its general design for head and neck imaging during MR procedures.