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Medrad Envision CT Injector System

by Medrad, Inc.

510(k) K993728

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 NumberK993728 Date26 Nov 1999ClearedStatusActive

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  • Withdrawn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, 27 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 Envision CT Injector System is an angiographic injector and syringe system designed for the controlled delivery of contrast media. It functions as a flow-controlled fluid delivery system that allows operators to select specific flow rates for contrast administration during computed tomography procedures.

This device is intended for use in clinical settings to provide control over contrast injection into the patient. It is supplied as a system component and is subject to FDA 510(k) authorization under regulation number 870.1650.

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Questions

AI-generated answers, 27 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 primary function of the Medrad Envision CT Injector System?

    This device is a flow-controlled fluid delivery system designed for the controlled administration of contrast media during computed tomography procedures, allowing operators to select specific flow rates.

  • What is the regulatory status of this device?

    The Medrad Envision CT Injector System is subject to FDA 510(k) authorization under regulation number 870.1650.

  • In what clinical environment is this system intended to be used?

    The system is intended for use in clinical settings to provide precise control over contrast injection into the patient during diagnostic imaging procedures.