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

Q: What is the product code of K152361?

The FDA product code is IZQ – Injector, Contrast Medium, Automatic, a Class II (moderate risk) device regulated under 21 CFR 870.1650.

FDA 510(k) K152361 · Liebel-Flarsheim Company, LLC

Substantially Equivalent

510(k) numberK152361

Submission

Device name: OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System
Applicant: Liebel-Flarsheim Company, LLC
Cincinnati, OH, US
Received: August 20, 2015
Decision date: January 14, 2016
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: IZQ – Injector, Contrast Medium, Automatic
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.1650
Specialty: Cardiovascular

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K252281	ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT…IZQ · Traditional	Ulrich GmbH & Co. KG	11/18/2025SE
K251295	ulrichINJECT CT Motion (XD 8000)IZQ · Traditional	Ulrich GmbH & Co. KG	11/07/2025SE
K252689	MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient…IZQ · Special	Imaxeon Pty, Ltd.	09/24/2025SE
K241849	MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient…IZQ · Traditional	Imaxeon Pty, Ltd.	11/05/2024SE
K241850	ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT…IZQ · Traditional	Ulrich GmbH & Co. KG	08/26/2024SE
K233737	ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT…IZQ · Traditional	Ulrich GmbH & Co. KG	04/19/2024SE
K210541	ulrichINJECT CT motionIZQ · Traditional	Ulrich GmbH & Co. KG	08/06/2021SE
K192872	ulrichINJECT CT MotionIZQ · Traditional	Ulrich GmbH & Co. KG	07/02/2020SE
K171392	ulrichINJECT CT motionIZQ · Traditional	Ulrich GmbH & Co. KG	11/09/2017SE

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Questions and answers

When was OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System cleared by the FDA?

OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System (K152361) received a 510(k) decision of Substantially Equivalent on January 14, 2016, 147 days after the submission was received.

What is the product code of K152361?

The FDA product code is IZQ – Injector, Contrast Medium, Automatic, a Class II (moderate risk) device regulated under 21 CFR 870.1650.