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FDA clearedFDA cleared. Stage 4 of 4 (Authorized)

FDA Clears Bayer's MEDRAD MRXperion MR Injector for Scanners Up to 7 Tesla

The updated clearance for the contrast injector also adds a module that lets it communicate with the MRI scanner.

By News DeskMarch 4, 20262 min read
A contrast injector on a stand next to a CT scanner
A Bayer MEDRAD contrast injector beside a Siemens CT scanner. This is not the MRXperion MR injection system described in this article. Mike.mcdermott7, CC BY-SA 4.0, via Wikimedia Commons · CC BY-SA 4.0
FDA cleared510(k) · K252891FDA cleared. Stage 4 of 4 (Authorized)

The FDA cleared this device through the 510(k) pathway, which finds it substantially equivalent to a device already on the market. Clearance is not the same as approval.

Key points

  • The FDA cleared an updated MEDRAD MRXperion MR Injection System and a new ISI2 scanner-interface module under 510(k) K252891 on February 13, 2026; Bayer announced it on March 3.
  • The labeled magnetic field range widened from 0.7 to 3.0 Tesla to up to and including 7.0 Tesla; the 510(k) summary says no hardware or software changes were needed for that.
  • The submission also added cybersecurity changes, including a Trusted Platform Module and message authentication between the injector's two units.

The US Food and Drug Administration has cleared expanded capabilities for Bayer's MEDRAD MRXperion MR Injection System, a power injector that delivers contrast agents and saline during MRI exams, so that it can be used with scanners of up to 7 Tesla, Medical Economics reported after Bayer's announcement on March 3.

The clearance also covers Imaging Scanner Interface 2 (ISI2), which Bayer said enables communication between the injector and the scanner to help coordinate exams.

What the FDA record shows

The FDA's 510(k) database lists the decision as K252891 for the MEDRAD MRXperion MR Injection System and Syringe Kit and the MEDRAD ISI2 Module. The agency received the traditional 510(k) from Bayer Medical Care on September 11, 2025, and found the device substantially equivalent on February 13, 2026. It is classed as an angiographic injector and syringe.

The 510(k) summary names the previous MRXperion clearance, K182276, as the predicate. It says the magnetic field strength range was expanded from "0.7T to 3.0T" to "Up to and including 7.0T" and that "There were no hardware or software device modifications needed to support this expanded magnetic field strength range." The field strength range was moved out of the indications for use and into a warning in the operation manual.

The ISI2 module is described as an optional hardware accessory with embedded software that lets the injector interface with an MR scanner, synchronizing scan timing. The summary also lists security changes: a Trusted Platform Module 2.0 added to the workstation for hardware-based cryptographic protection, a bootloader update, a self-upgrade feature for cybersecurity-related software updates and message authentication between the scan room unit and control room unit.

The system uses a single-use kit with one 65 mL syringe for contrast media and one 115 mL syringe for saline, and it is intended for adults and children, according to the summary. The summary notes that MRXperion was subject to a design-related recall in June 2016 that was closed in December 2016.

Bayer's account

"The clearance also exemplifies our continued innovation in MR solutions to consistently meet the needs of today's imaging providers," said Jill Carbone, vice president and head of Radiology North America Product & Pipeline at Bayer, as quoted by Medical Economics.

Bayer described MRXperion as a piston-technology power injector and said the system is engineered to support uses ranging from routine clinical imaging to advanced research applications. Ultra-high-field scanners at 7 Tesla and above have gained traction in research institutions and some clinical centers, Medical Economics noted.

Bayer did not give a date for when the expanded labeling or the ISI2 module would reach customers in the coverage reviewed.

Sources

  1. FDA clears Bayer's MR injection system for ultra-high-field imaging, Medical Economics, March 4, 2026
  2. 510(k) K252891: MEDRAD MRXperion MR Injection System and Syringe Kit; MEDRAD ISI2 Module (database record), US Food and Drug Administration, February 13, 2026
  3. K252891 510(k) summary, US Food and Drug Administration, February 13, 2026