# K152361: OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System

- Pathway: 510(k) (Traditional)
- Applicant: Liebel-Flarsheim Company, LLC
- Decided: Jan 14, 2016 after 147 days
- Product code: IZQ (Injector, Contrast Medium, Automatic)
- Device class: 2
- Regulation: 21 CFR 870.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K912944 (1992). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063503: Optivantage DH Injector System with Enhanced Communication, Mallinckrodt Inc., Liebel-Flarsheim Business (2007) Summary page 4.

## Indications for use
The OptiOne Single-Head Contrast Delivery System is a contrast delivery system and is designed to inject radiopaque contrast media into a patient’s vascular system to obtain diagnostic images when used with computed tomography (i.e. “CT”) equipment.

Source page: https://510kreport.com/device/K152361
Methodology: https://510kreport.com/methodology