DeviceClearance

MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)— 510(k) K252891

Substantially Equivalent

Bayer Medical Care, Inc.

FDA 510(k) clearance K252891 for MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2), Substantially Equivalent on 2026-02-13. Applicant: Bayer Medical Care, Inc.. Device class: 2.

Summary

Bayer Medical Care lists the MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit, plus the MEDRAD ISI2 Module (ISI2), under product code DXT (Injector And Syringe, Angiographic). The record doesn't describe them beyond those names.

Class II, 21 CFR 870.1650. The General Hospital review panel handled it as a Traditional 510(k), though the record lists Cardiovascular as the classification panel.

The record lists the applicant location as Indianaola, Pennsylvania. The decision came 155 calendar days after FDA received it (September 11, 2025 to February 13, 2026), and it was substantially equivalent.

Clearance details

Applicant
Bayer Medical Care, Inc.
Product code
Product code DXT
Device class
Class 2
Regulation
21 CFR 870.1650
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Indianaola, PA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code DXT

product code DXT
Death
39
Injury
242
Malfunction
463
Other
3
Total
747

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.