Mallinckrodt Inc., Liebel-Flarsheim Business
United StatesFDA applicant, unverified
- Devices
- 8
What Mallinckrodt Inc., Liebel-Flarsheim Business makes
The company manufactures automated injection systems for medical imaging, including the OptiStar Elite, OptiVantage DH, and OptiVantage DH with enhanced communication features. These devices are designed for contrast agent delivery in radiology procedures, such as computed tomography (CT) and magnetic resonance imaging (MRI). Additional offerings include the Optibolus, a contrast agent injector, and syringe-based systems like the Syringe with Handi-Fil for manual or semi-automated contrast administration. The portfolio also includes the Elph Injection System and the Angiomat Illumina, specialized for angiographic and vascular imaging applications.
All listed devices fall under FDA Class II regulation and are authorised via the 510(k) pathway. The company’s products are registered with the FDA’s 510(k) clearance system. The manufacturer is based in the United States.
Catalogue
Optistar Elite Injection System Ref K073592
Regimes: 510(k) Registry: 510(k)Optiv Antage Dh Power Injection System Ref K042744
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Optibolus Ref K031339
Regimes: 510(k) Registry: 510(k)Syringe With Handi-Fil Ref K082212
Regimes: 510(k) Registry: 510(k)Optistar Mr Injector System Ref K984088
Regimes: 510(k) Registry: 510(k)Elph Injection System Ref K022116
Regimes: 510(k) Registry: 510(k)Angiomat Illumena Ref K963071
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Mallinckrodt Inc., Liebel-Flarsheim Business have in the registry?
The registry currently lists 8 devices for Mallinckrodt Inc., Liebel-Flarsheim Business. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mallinckrodt Inc., Liebel-Flarsheim Business's devices?
Among its 8 most recently registered devices, Mallinckrodt Inc., Liebel-Flarsheim Business has devices listed in FDA 510(k) (8 devices).
What risk classes do Mallinckrodt Inc., Liebel-Flarsheim Business's devices fall under?
Among its 8 most recently registered devices, the classes recorded for Mallinckrodt Inc., Liebel-Flarsheim Business's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Mallinckrodt Inc., Liebel-Flarsheim Business in the registry?
The most recently registered devices listed for Mallinckrodt Inc., Liebel-Flarsheim Business include OPTISTAR ELITE INJECTION SYSTEM, OPTIV ANTAGE DH POWER INJECTION SYSTEM, OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION and OPTIBOLUS.