Injector, Contrast Medium, Automatic

FDA product code IZQ · 23 cleared devices

Class 2 Cardiovascular

Regulation: 21 CFR 870.1650
Review panel: HO
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-10-08 – 2026-08-03

IZQ 2026-08-03

VueJect® Ultrasound Enhancing Agent Delivery System

Applicant ACIST Medical Systems, Inc.

K number K262115

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IZQ 2025-11-18

ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)

Applicant Ulrich GmbH & Co. KG

K number K252281

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IZQ 2025-11-07

ulrichINJECT CT Motion (XD 8000)

Applicant Ulrich GmbH & Co. KG

K number K251295

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IZQ 2025-09-24

MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)

Applicant Imaxeon Pty, Ltd.

K number K252689

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IZQ 2024-11-05

MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)

Applicant Imaxeon Pty, Ltd.

K number K241849

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IZQ 2024-08-26

ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)

Applicant Ulrich GmbH & Co. KG

K number K241850

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IZQ 2024-04-19

ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)

Applicant Ulrich GmbH & Co. KG

K number K233737

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IZQ 2021-08-06

ulrichINJECT CT motion

Applicant Ulrich GmbH & Co. KG

K number K210541

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IZQ 2020-07-02

ulrichINJECT CT Motion

Applicant Ulrich GmbH & Co. KG

K number K192872

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IZQ 2017-11-09

ulrichINJECT CT motion

Applicant Ulrich GmbH & Co. KG

K number K171392

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IZQ 2016-01-22

CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set

Applicant Bracco Injeneering

K number K151048

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IZQ 2016-01-14

OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System

Applicant Liebel-Flarsheim Company, LLC

K number K152361

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IZQ 2010-05-21

SONIC SHOT GX

Applicant Nemoto Kyorindo Co., Ltd.

K number K091734

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IZQ 2007-04-27

OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION

Applicant Mallinckrodt Inc., Liebel-Flarsheim Business

K number K063503

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IZQ 2007-04-13

EMPOWERMR INJECTOR SYSTEM, MODEL 9730

Applicant E-Z-Em, Inc.

K number K062449

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IZQ 2007-03-27

MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY

Applicant Medrad, Inc.

K number K063090

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IZQ 2006-12-26

CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM

Applicant Swiss Medical Care S.A.

K number K062265

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IZQ 2003-06-19

EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825

Applicant E-Z-Em, Inc.

K number K031571

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IZQ 1999-02-19

PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM

Applicant Nycomed Amersham Imaging

K number K983314

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IZQ 1999-02-11

ACIST INJECTOR SYSTEM, MODEL CL100 H

Applicant Acist Medical Systems

K number K984058

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IZQ 1995-05-04

KENEX INJECTOR HEAD SUPPORT (AS EXHIBIT 2)

Applicant Kenex , Ltd.

K number K951005

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IZQ 1976-10-08

MYELOGRAPHY TRAY W/CUATICO MYELOGRAP N

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K760643

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IZQ 1976-10-08

MYELOGRAPHY TRAY W/CHYNN MYELOGRAPHY N

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K760641

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