FDA 510(k) clearance · back to tracker

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

Bayer Medical Care, Inc. cleared K262043 on 2026-10-06, decision: substantially equivalent

K-number

K262043

Sponsor

Bayer Medical Care, Inc.

Device

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

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-10-06

Product code

DXT

Advisory committee

Cardiovascular

Medical specialty

Cardiovascular

Regulation number

870.1650

Official FDA record

Open K262043on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Drop K262043 into Compass and start a substantial-equivalence draft.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.