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Liebel-Flarsheim Company, LLC

United States·US-MF-000002605

Last updated May 23, 2026

What Liebel-Flarsheim Company, LLC makes

Liebel-Flarsheim Company, LLC manufactures a range of stationary, line‑powered injection systems for delivering contrast media in angiography, CT, and MRI procedures, as well as related accessories such as angiography kits, angiographic syringes, general‑purpose fluid transfer sets, radiographic procedure tubing, and a multi‑purpose warming cabinet.

The devices are classified as Class I, Class II, and Class IIb and are listed in the FDA UDI database and the EU’s Eudamed registry; the company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What does Liebel-Flarsheim Company, LLC manufacture?

Liebel-Flarsheim Company, LLC manufactures stationary, line-powered injection systems for delivering contrast media in angiography, CT, and MRI procedures, along with related accessories like angiography kits, angiographic syringes, fluid transfer sets, radiographic procedure tubing, and a multi-purpose warming cabinet.

Where is Liebel-Flarsheim Company, LLC based?

Liebel-Flarsheim Company, LLC is based in the United States, as indicated by the country designation in the device data.

Which regulatory registries list Liebel-Flarsheim's devices?

Liebel-Flarsheim's devices are listed in the FDA UDI database and the EU's Eudamed registry, as specified in the device data.

How are Liebel-Flarsheim's devices classified?

Liebel-Flarsheim's devices are classified as Class I, Class II, and Class IIb, which reflects their varying levels of risk and regulatory control requirements.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: United States
Address: 2111, E. Galbraith Road, Cincinnati, United States
Website: guerbet.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Jacob Miller
EUDAMED SRN: US-MF-000002605
FDA FEI Number: —
DUNS Number: —

Catalogue (128)

Page 3 of 3

Device	Model / Reference	Registries	Class	Status
Lf	DL814001	FDA UDI	Class II	Unknown
Lf	844021P	FDA UDI	Class II	Unknown
Lf	844021	FDA UDI	Class II	Active
Lf	801107	FDA UDI	Class II	Active
Lf	802622	FDA UDI	Class II	Active
Lf	900563	FDA UDI	Class I	Active
Lf	600269P	FDA UDI	Class II	Unknown
Lf	900101	FDA UDI	Class II	Unknown
Lf	900210	FDA UDI	Class II	Active
Lf	847003C	FDA UDI	Class II	Active
Lf	9896 001 30321	FDA UDI	Class I	Active
Lf	900688	FDA UDI	Class I	Active
Lf	DE900001	FDA UDI	Class II	Unknown
Liebel-Flarsheim Direct Digital Imaging System	K121838	FDA 510(k)	Class II	Active
Liebel-Flarsheim IBP Transfer Set	K193010	FDA 510(k)	Class II	Active
OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System	K152361	FDA 510(k)	Class II	Active
Optivantage	849002	EUDAMEDFDA UDI	Class IIb	Active
Illumena Neo	900001	EUDAMEDFDA UDI	Class IIb	Active
Optistar	814002	EUDAMEDFDA UDI	Class IIb	Active
Optivantage	844007	EUDAMEDFDA UDI	Class IIb	Active
Optivantage	844008	EUDAMEDFDA UDI	Class IIb	Active
Optistar	814005	EUDAMEDFDA UDI	Class IIb	Active
Optistar	814006	EUDAMED	Class IIb	Active
Optivantage	844005	EUDAMEDFDA UDI	Class IIb	Active
Illumena Neo	900006	EUDAMEDFDA UDI	Class IIb	Active
Optistar	814004	EUDAMEDFDA UDI	Class IIb	Active
Optistar	814001	EUDAMEDFDA UDI	Class IIb	Active
Optivantage	844009	EUDAMED	Class IIb	Active

Related Companies

Authorised Representatives

Guerbet FR

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (3)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Mar 11, 2021	Z-1992-2021	—	terminated	Failure to comply with the performance standard for fluoroscopy systems. Per 21 CFR 1020.32(k)(6), the displayed AKR and cumulative air kerma shall not deviate from the actual values by more than 35 percent. The dosage displayed on the generator console and table display (monitor) is higher than the actual delivered dose.
Feb 27, 2017	Z-2833-2018	—	terminated	Software issue. The difference between the display and dosimeter readings In the Child/Pediatric automatic exposure mode is in the range of 52-65%. The display in all other modes deviated by less than 35% from the dosimeter readings.
Feb 27, 2017	Z-2834-2018	—	terminated	Software issue. The difference between the display and dosimeter readings In the Child/Pediatric automatic exposure mode is in the range of 52-65%. The display in all other modes deviated by less than 35% from the dosimeter readings.