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HRK-123 Knee Array Coil

by Mri Devices Corporation

510(k) K050299

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 NumberK050299 Date24 Feb 2005ClearedStatusActive

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  • Withdrawn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, 25 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 Hrk-123 Knee Array Coil is a magnetic resonance diagnostic device that functions as a radiofrequency receiver coil to capture MR signals from the knee anatomy. It is an accessory for Magnetic Resonance scanners.

The Hrk-123 Knee Array Coil is supplied for use in radiology and is cleared under FDA 510(k) with the regulation number 21 CFR 892.1000. It was cleared in 2005 under K-number K050299.

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Questions

AI-generated answers, 25 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 HRK-123 Knee Array Coil used for?

    The HRK-123 Knee Array Coil is used as a radiofrequency receiver coil to capture MR signals from the knee anatomy in radiology applications.

  • Is the HRK-123 Knee Array Coil cleared by the FDA?

    Yes, the HRK-123 Knee Array Coil is cleared under FDA 510(k) with the regulation number 21 CFR 892.1000, and was cleared in 2005 under K-number K050299.

  • What type of device is the HRK-123 Knee Array Coil?

    The HRK-123 Knee Array Coil is a magnetic resonance diagnostic device and an accessory for Magnetic Resonance scanners.