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Medrad MRI Injection System

by Medrad, Inc.

510(k) K873173

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 NumberK873173 Date5 Feb 1988ClearedStatusActive

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  • Withdrawn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
DXT
Device Class
Class II
Regulation
21 CFR Part 870.1650
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Medrad MRI Injection System is a power injector (Device Type: Injector and Syringe, Angiographic) designed for administering contrast agents and saline during contrast-enhanced MRI procedures. It automates precise, high-pressure fluid delivery to enhance diagnostic imaging accuracy in cardiovascular and angiographic studies.

This system is single-use, intended for use in MRI-compatible environments and supplied sterile. It operates via piston technology and is regulated under FDA 510(k) clearance (K873173) as a Class II device (Regulation Number: 870.1650). Multiple model variants are listed under FEI numbers, reflecting different configurations for clinical applications.

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