# K073592: Optistar Elite Injection System

- Pathway: 510(k) (Traditional)
- Applicant: Mallinckrodt Inc., Liebel-Flarsheim Business
- Decided: May 7, 2008 after 139 days
- Product code: DXT (Injector And Syringe, Angiographic)
- 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: 2 generations back to K935668 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984088: Optistar MR Injector System, Mallinckrodt Inc., Liebel-Flarsheim Business (1999) Summary page 2.

## Indications for use
The Optistar Elite Injection System is a contrast delivery system and is designed to inject MR contrast media and flushing solutions into a patient's vascular system to obtain diagnostic images when used with Magnetic Resonance Imaging equipment.

Source page: https://510kreport.com/device/K073592
Methodology: https://510kreport.com/methodology