# K042744: Optiv Antage DH Power Injection System

- Pathway: 510(k) (Special)
- Applicant: Mallinckrodt Inc., Liebel-Flarsheim Business
- Decided: Nov 30, 2004 after 57 days
- Product code: DXT (Injector And Syringe, Angiographic)
- 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: 2 generations back to K912944 (1992). 2 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031339: Optibolus, Mallinckrodt Inc., Liebel-Flarsheim Business (2003) Summary page 2.

## Most influential descendants
- K072886: Medrad Stellant CT Injector System with P3T (2007), 7 descendants of its own
- K082905: Medrad Stellant CT Injector System with P3T Cardiac (2009), 5 descendants of its own
- K173773: MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT (2018), 4 descendants of its own
- K182273: MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT (2018), 3 descendants of its own
- K063503: Optivantage DH Injector System with Enhanced Communication (2007), 2 descendants of its own

## Recalls of this device
- Nov 7, 2006 · Not classified · Z-0288-2007: The flow rate programmed on the console may be changed without automatically updating the flow rate programmed on the power head. The injector will always inject in accordance with the parameters show

## Indications for use
The OptiVantage DH Injection 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/K042744
Methodology: https://510kreport.com/methodology