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HAC-12 and HAC-30 Head Array Coil

by Mri Devices Corp.

510(k) K033152

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK033152 Date10 Oct 2003ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MOS
Device Class
Class II
Regulation
21 CFR Part 892.1000
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The HAC-12 and HAC-30 Head Array Coil is a radiofrequency (RF) receiver coil used with Magnetic Resonance (MR) scanners. It detects MR signals from the head and neck anatomy, which are processed by the MR scanner to generate diagnostic images.

This device is supplied as a reusable component for use in clinical MR imaging settings. It has received FDA 510(k) clearance under K033152, is classified as a Class II device with product code MOS, and falls under regulation number 892.1000 for coils, magnetic resonance, specialty, within the radiology medical specialty.

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Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the HAC-12 and HAC-30 Head Array Coil used for?

    The HAC-12 and HAC-30 Head Array Coil is a radiofrequency receiver coil used with Magnetic Resonance scanners to detect MR signals from the head and neck anatomy, which are processed by the scanner to generate diagnostic images.

  • Is the HAC-12 and HAC-30 Head Array Coil reusable or single-use?

    The device is supplied as a reusable component for use in clinical MR imaging settings, meaning it is designed for multiple uses after proper cleaning and handling according to manufacturer guidelines.

  • What regulatory pathway was used for the HAC-12 and HAC-30 Head Array Coil?

    The HAC-12 and HAC-30 Head Array Coil received FDA 510(k) clearance under submission K033152, demonstrating substantial equivalence to a legally marketed predicate device.