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FDA 510(k)

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

K-Number: K152361 · 2016-01-14

ApplicantLiebel-Flarsheim Company, LLC
Decision Date2016-01-14
Product CodeIZQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System is the device name listed in this FDA 510(k) record. The listed applicant is Liebel-Flarsheim Company, LLC. It received FDA 510(k) clearance on 2016-01-14 under 510(k) number K152361. The device is classified under product code IZQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System?

OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System is a medical device that received FDA 510(k) clearance on 2016-01-14. The listed applicant is Liebel-Flarsheim Company, LLC. The 510(k) number is K152361.

When did OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System receive FDA 510(k) clearance?

OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System received FDA 510(k) clearance on 2016-01-14, under 510(k) number K152361.

Who is the listed applicant for OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System?

The FDA 510(k) record lists Liebel-Flarsheim Company, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System?

The FDA product code for OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System is IZQ.

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Other records listing Liebel-Flarsheim Company, LLC as applicant

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Related Devices (Code: IZQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262115VueJect® Ultrasound Enhancing Agent Delivery SystemACIST Medical Systems, Inc.K252281ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)Ulrich GmbH & Co. KGK251295ulrichINJECT CT Motion (XD 8000)Ulrich GmbH & Co. KGK252689MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)Imaxeon Pty, Ltd.K241849MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)Imaxeon Pty, Ltd.K241850ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)Ulrich GmbH & Co. KG

Official Source

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