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MRP-5000 HS/MR Quadrature Body Coil (P/N MR-QBC-31)

by Hitachi Medical Systems America, Inc.

510(k) K914019

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 NumberK914019 Date1 Nov 1991ClearedStatusActive

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  • Withdrawn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, 24 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 HS/MR Quadrature Body Coil is a device used for nuclear magnetic resonance imaging. It is designed to be part of an MRI system for body imaging applications.

This device is supplied by Hitachi Medical Systems America, Inc. and is a Class II medical device. It has FDA 510(k) clearance with number K914019, received in 1991, and is regulated under 892.1000.

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