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

The MEDRAD MRXperion MR Injection System is a syringe-based fluid delivery device for administering intravenous MR contrast media and saline during MRI procedures. It consists of a Scan Room Unit and Control Room Unit with disposable dual syringes (65 mL and 115 mL) and is intended for use by trained healthcare professionals in diagnostic magnetic resonance imaging applications.

The subject device adds an optional ISI2 Module accessory that enables the injector to interface with MR scanner systems, expanding the magnetic field strength compatibility from 0.7T–3.0T to up to 7.0T. Hardware additions include a Trusted Platform Module 2.0 for cryptographic protection and a Head Interface Card Bootloader update. Software modifications include authenticated self-upgrade capability and Hash-Based Message Authentication Code implementation between system components. The syringe kit, operational parameters, and core injection functionality remain unchanged from the predicate.

IEC 62304 (Medical Device Software lifecycle), IEC 62366-1 (Usability engineering), IEC 60601-1 and IEC 60601-1-2 (Electrical safety and EMC), IEC TS 60601-4-2 (EMC guidance), AAMI/UL 2800-1 series (Interoperability), FDA Guidance on Cybersecurity in Medical Devices (June 2025), FDA Guidance on Testing and Labeling Medical Devices for Safety in the MR Environment (October 2023), and FDA Guidance on Device Software Functions (June 2023).