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Mobile MRP-20 Magnetic Resonance Diagnostic Device

by Summit World Trade Corp.

510(k) K901980

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 NumberK901980 Date28 Jun 1990ClearedStatusActive

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  • Withdrawn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, 1 Oct 2026

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

The Mobile MRP-20 Magnetic Resonance Diagnostic Device is a Class II MRI scanner system used for diagnostic imaging in radiology. It is designed to provide nuclear magnetic resonance imaging capabilities in a mobile configuration.

The device is manufactured by Summit World Trade Corp. and is supplied as a mobile unit. It received FDA 510(k) clearance with K number K901980 on June 28, 1990, and is regulated under product code LNH. The device is intended for use in radiology settings.

Other devices from Summit World Trade Corp.

See all devices from Summit World Trade Corp. →

Questions

AI-generated answers, 1 Oct 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 Mobile MRP-20 Magnetic Resonance Diagnostic Device used for?

    The Mobile MRP-20 is a Class II MRI scanner system designed for diagnostic imaging in radiology. It provides nuclear magnetic resonance imaging capabilities in a mobile configuration, allowing for flexible imaging solutions in various healthcare settings.

  • How is the Mobile MRP-20 MRI device supplied?

    The Mobile MRP-20 Magnetic Resonance Diagnostic Device is supplied as a complete mobile unit by Summit World Trade Corp. It is designed to be transported and set up at different locations as needed for diagnostic imaging procedures.

  • What regulatory approvals does the Mobile MRP-20 MRI have?

    The Mobile MRP-20 received FDA 510(k) clearance with K number K901980 on June 28, 1990. It is regulated under product code LNH and is classified as substantially equivalent to predicate devices for nuclear magnetic resonance imaging systems.

  • What are the specifications of the Mobile MRP-20 MRI device?

    The Mobile MRP-20 is a mobile MRI scanner system intended for use in radiology settings. It is a Class II device that provides nuclear magnetic resonance imaging capabilities. The device was manufactured by Summit World Trade Corp. and received FDA clearance through the traditional 510(k) pathway.