# K063503: Optivantage DH Injector System with Enhanced Communication

- Pathway: 510(k) (Special)
- Applicant: Mallinckrodt Inc., Liebel-Flarsheim Business
- Decided: Apr 27, 2007 after 158 days
- Product code: IZQ (Injector, Contrast Medium, Automatic)
- Device class: 2
- Regulation: 21 CFR 870.1650
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K912944 (1992). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042744: Optiv Antage DH Power Injection System, Mallinckrodt Inc., Liebel-Flarsheim Business (2004) Summary page 2.

## Most influential descendants
- K152361: OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System (2016), 0 descendants of its own
- K133600: Coeur, Inc. Frontload for Optivantage Power Injector (2014), 0 descendants of its own

## Recalls of this device
- Apr 7, 2008 · Not classified · Z-1694-2008: Screws can begin to loosen and shear off to the point of the J-Bow falling from the suspension system. This may cause injury to patients or hospital staff.

## Indications for use
The OptiVantage DH Injector System with Enhanced Communication 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/K063503
Methodology: https://510kreport.com/methodology