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MRP-5000 and 7000 Bilateral/Unilateral TMJ Coil

by Hitachi Medical Systems America, Inc.

510(k) K923140

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 · Traditional NumberK923140 Date24 Dec 1992ClearedStatusActive

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  • Withdrawn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
LNH
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 MRP-5000 and 7000 Bilateral/Unilateral TMJ Coil is a device used for Nuclear Magnetic Resonance Imaging. It is designed for use in radiology procedures.

This device is supplied by Hitachi Medical Systems America, Inc. and has FDA 510(k) clearance with the number K923140. It is a Class II device and is used in radiology settings.

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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 MRP-5000 and 7000 Bilateral/Unilateral TMJ Coil used for?

    This device is specifically designed for Nuclear Magnetic Resonance Imaging (MRI) procedures, particularly for imaging the temporomandibular joint (TMJ) in both bilateral and unilateral configurations.

  • How is the MRP-5000 and 7000 TMJ Coil supplied?

    The MRP-5000 and 7000 Bilateral/Unilateral TMJ Coil is supplied by Hitachi Medical Systems America, Inc. and is intended for use in radiology settings for diagnostic imaging procedures.

  • What is the regulatory status of the MRP-5000 and 7000 TMJ Coil?

    This device has FDA 510(k) clearance with the number K923140, making it a Class II device that is substantially equivalent to other legally marketed devices in its category.

  • What are the distinguishing features of the MRP-5000 and 7000 models?

    The MRP-5000 and 7000 Bilateral/Unilateral TMJ Coil are designed for both bilateral and unilateral imaging of the temporomandibular joint, providing flexibility in MRI examinations while maintaining compatibility with Hitachi MRI systems.