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Modification to Medrad Spectris MR Injector

by Medrad, Inc.

510(k) K011991

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 NumberK011991 Date21 Aug 2001ClearedStatusActive

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  • Withdrawn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, 26 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 Modification to Medrad Spectris MR Injector is a syringe-based fluid delivery system designed for the injection of contrast media during Magnetic Resonance Imaging procedures. This device is classified as an Injector and Syringe, Angiographic, and is intended for use in cardiovascular applications.

The device is a modification to the existing Medrad Spectris MR Injector system and is supplied as a Class II medical device under special controls. It is authorized for use in the United States with FDA 510(k) clearance K011991, which was granted on August 21, 2001. The device is manufactured by Medrad, Inc. in Indianola, Pennsylvania.

Other devices from Medrad, Inc.

See all devices from Medrad, Inc. →

Questions

AI-generated answers, 26 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 Modification to Medrad Spectris MR Injector used for?

    This device is a syringe-based fluid delivery system specifically designed for the injection of contrast media during Magnetic Resonance Imaging procedures, with particular applications in cardiovascular imaging.

  • How is the Modification to Medrad Spectris MR Injector supplied?

    The device is supplied as a Class II medical device under special controls. It is a modification to the existing Medrad Spectris MR Injector system and is manufactured by Medrad, Inc. in Indianola, Pennsylvania.

  • What is the regulatory status of this device?

    The Modification to Medrad Spectris MR Injector is authorized for use in the United States with FDA 510(k) clearance K011991, which was granted on August 21, 2001. It is classified as an Injector and Syringe, Angiographic.

  • What is the device classification and product code?

    This device is classified as a Class II medical device under special controls with the product code DXT. It is categorized as an Injector and Syringe, Angiographic, intended for cardiovascular applications.