# K252891: MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Medical Care, Inc.
- Decided: Feb 13, 2026 after 155 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: 5 generations back to K012950 (2001). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182276: MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit, Bayer Medical Care, Inc. (2018) Summary page 5.

## 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 procedures. 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. Only trained healthcare professionals are intended to operate this device. For a complete list of compatible contrast agents for use with the MEDRAD® MRXperion MR Injection System, refer to the MRXperion MR Injection System operation manual. The ISI2 Module is indicated for the specific purpose of allowing an injector to interface with an imaging scanner.

Source page: https://510kreport.com/device/K252891
Methodology: https://510kreport.com/methodology