# K042784: Medrad Spectris Solaris EP MR Injector System

- Pathway: 510(k) (Special)
- Applicant: Medrad, Inc.
- Decided: Dec 10, 2004 after 65 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.
4 later devices descend from it; 2 cite it directly.
0 of 7 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 1.

## Most influential descendants
- K143538: MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit (2015), 2 descendants of its own
- K182276: MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit (2018), 1 descendant of its own
- K252891: MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2) (2026), 0 descendants of its own
- K091734: Sonic Shot GX (2010), 0 descendants of its own

## Indications for use
The Spectris Solaris EP MR Injection System is a syringe-based fluid delivery system indicated for delivery of contrast media during MR applications. It is intended to be used for the specific purpose of injecting intravenous MR contrast media and common flushing solutions into the human vascular system for diagnostic studies in magnetic resonance imaging (MRI) procedures. Only trained healthcare professionals are intended to operate this device.

Source page: https://510kreport.com/device/K042784
Methodology: https://510kreport.com/methodology