Device Listing 1522854545

Listing Summary#

Listing key
1522854545
Premarket submission
K262043
Device
MEDRAD® MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD® IS12 Module (IS12); MEDRAD® Imaging Bulk Package Transfer Spike
Applicant
Bayer Medical Care, Inc.
Product code
DXT
Decision date
2026-10-06