# K022116: Elph Injection System

- Pathway: 510(k) (Special)
- Applicant: Mallinckrodt Inc., Liebel-Flarsheim Business
- Decided: Jul 26, 2002 after 25 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: 1 generation back to K912944 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912944: CT 8000 Digital Injection System, Mallinckrodt Group, Inc. (1992) Summary page 2.

## Indications for use
The ELPH Injection System is a contiast delivery system which 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/K022116
Methodology: https://510kreport.com/methodology