Optivantage DH Injector System with Enhanced Communication
FDA 510(k) K063503 · Mallinckrodt Inc., Liebel-Flarsheim Business
510(k) numberK063503
Submission
- Device name
- Optivantage DH Injector System with Enhanced Communication
- Applicant
- Mallinckrodt Inc., Liebel-Flarsheim Business
Cincinnati, OH, US - Received
- November 20, 2006
- Decision date
- April 27, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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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|---|---|---|---|
| K262115 | VueJect® Ultrasound Enhancing Agent Delivery SystemIZQ · Traditional | ACIST Medical Systems, Inc. | 08/03/2026SE |
| 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 |
More from Ulrich GmbH & Co. KG
| 510(k) | Device | Decision |
|---|---|---|
| K082212 | Syringe with Handi-FilDXT · Special | 01/22/2009SE |
| K073592 | Optistar Elite Injection SystemDXT · Traditional | 05/07/2008SE |
| K042744 | Optiv Antage DH Power Injection SystemDXT · Special | 11/30/2004SE |
| K031339 | OptibolusDXT · Special | 07/11/2003SE |
| K022116 | Elph Injection SystemDXT · Special | 07/26/2002SE |
| K984088 | Optistar MR Injector SystemDXT · Traditional | 12/06/1999SE |
| K963071 | Angiomat IllumenaDXT · Traditional | 09/23/1997SE |
Questions and answers
When was Optivantage DH Injector System with Enhanced Communication cleared by the FDA?
Optivantage DH Injector System with Enhanced Communication (K063503) received a 510(k) decision of Substantially Equivalent on April 27, 2007, 158 days after the submission was received.
What is the product code of K063503?
The FDA product code is IZQ – Injector, Contrast Medium, Automatic, a Class II (moderate risk) device regulated under 21 CFR 870.1650.