510(k) clearance

MEDRAD® MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD® IS12 Module (IS12); MEDRAD® Imaging Bulk Package Transfer Spike

FDA 510(k) source

510(k) number

K262043

Applicant

Bayer Medical Care, Inc.

Decision date

Oct 6, 2026

Date received

Jun 17, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

DXT

Device type

Injector And Syringe, Angiographic

Device class

Class II

Regulation

21 CFR 870.1650

Advisory committee

Cardiovascular

Statement or summary

Summary

Third party

N

Location

Indianola, PA, US