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MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT

by Bayer Medical Care Inc. 2 variants

510(k) K173773

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K173773↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK173773 Date17 Aug 2018ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

1 recall · FDA

    • Terminated Z-0745-2019 FDA Class II initiated 14 Dec 2018

    If the head mount knob is not properly tightened and the operator directly uses the injector head to move the unit, it may become disengaged, causing the injector head to become loose or fall.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
DXT
FDA applicant
Bayer Medical Care, Inc.
Device Class
Class II
Regulation
21 CFR Part 870.1650
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 Stellant FLEX CT Injection System is a dual-syringe injector designed for computed tomography (CT) contrast media administration. It delivers precise, high-flow contrast injection to enhance vascular and organ imaging, supporting diagnostic procedures in cardiovascular, pulmonary, and abdominal studies.

This system is intended for single-patient use and includes adaptable syringe kits, connector tubing for various anatomical applications, and a Certegra Workstation for workflow integration. Supplied as a reusable medical device, it requires sterile preparation for each use and is regulated under FDA 510(k) and EU MDR. The system is classified as Class II and includes multiple FEI and registration numbers for regulatory tracking.

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