# K012950: Modification to: Medrad Spectris Solaris MR Injector System

- Pathway: 510(k) (Special)
- Applicant: Medrad, Inc.
- Decided: Oct 4, 2001 after 30 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
No predicates in its family tree.
9 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K033247: Medrad Spectris Solaris MR Injector System (2003), 7 descendants of its own
- K042784: Medrad Spectris Solaris EP MR Injector System (2004), 4 descendants of its own
- 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
- K161471: MR Syringe Dual Pack for Solaris Injectors (2016), 1 descendant of its own

## Indications for use
The Spectris Solaris MR Injection System is a syringe-based fluid delivery system indicated for delivery of contrast media during computed tomography applications. It is intended to be used for the specific purpose of injecting intravenous contrast medium into the human vascular system for diagnostic studies in computed tomography. Only trained healthcare professionals are intended to operate this device.

Source page: https://510kreport.com/device/K012950
Methodology: https://510kreport.com/methodology