# K161471: MR Syringe Dual Pack for Solaris Injectors

- Pathway: 510(k) (Traditional)
- Applicant: Coeur, Inc.
- Decided: Oct 6, 2016 after 132 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 K012950 (2001). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033247: Medrad Spectris Solaris MR Injector System, Medrad, Inc. (2003) Summary page 4.

## Most influential descendants
- K170431: CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), Single Fascia and Ram Tip, Dual Fascia and Ram Tip (2017), 0 descendants of its own

## Indications for use
For use with the Medrad Spectris® Solaris™ MR Injection System for the injection of contrast media or saline to the vascular system for diagnostic purposes.

Source page: https://510kreport.com/device/K161471
Methodology: https://510kreport.com/methodology