# K143538: MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Medical Care, Inc.
- Decided: Aug 14, 2015 after 242 days
- Product code: DXT (Injector And Syringe, Angiographic)
- Device class: 2
- Regulation: 21 CFR 870.1650
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K012950 (2001). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042784: Medrad Spectris Solaris EP MR Injector System, Medrad, Inc. (2004) Summary page 4.

## Most influential descendants
- 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

## Recalls of this device
- Jun 9, 2016 · Class II · Z-2244-2016: Bayer Healthcare is initiating this recall due to complaints that were received from customer sites describing a 4205 error message when the injector is used with a 3T scanner.

## Indications for use
The MEDRAD® MRXperion MR Injection System is a syringe-based fluid delivery system indicated for delivery of contrast media and saline during MR applications. It is intended to be used for the specific purpose of injecting intravenous MR contrast media and saline into the human vascular system for diagnostic studies in magnetic resonance imaging (MRI) applications with MRI scanners that have a magnetic field strength between 0.7 and 3.0 Tesla. Only trained healthcare professionals are intended to operate this device.

Source page: https://510kreport.com/device/K143538
Methodology: https://510kreport.com/methodology