MEDRAD® MRXperion MR Injection System and MR Injection System Syringe Kit +2 more— 510(k) K262043
Substantially EquivalentBayer Medical Care, Inc.
FDA 510(k) clearance K262043 for MEDRAD® MRXperion MR Injection System and MR Injection System Syringe Kit +2 more, Substantially Equivalent on 2026-10-06. Applicant: Bayer Medical Care, Inc.. Device class: 2.
Summary
Bayer Medical Care's clearance covers the MEDRAD MRXperion MR Injection System and its syringe kit, the MEDRAD IS12 Module (IS12), and the MEDRAD Imaging Bulk Package Transfer Spike. Product code DXT is angiographic injectors and syringes.
Class II, 21 CFR 870.1650. The General Hospital review panel handled it as a Traditional 510(k); the record lists Cardiovascular as the classification panel.
Bayer Medical Care filed from Indianola, Pennsylvania. Review took 111 days (June 17 to October 6, 2026).
Clearance details
- Device name as filed
- 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
- 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
- Indianola, PA, US
Recent devices under product code DXT
view all- K252652 — Disposable Syringes with Accessories for Power Injectors (7+ models)
- K252638 — VeraPro S100 Multi-Use Syringe (018808) +4 more
- K252653 — ACIST Pro Diagnostic System (019304) +5 more
- K253048 — High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube
- K251788 — Extension tube
More clearances from Bayer Medical Care, Inc.
view all- K253688 — MEDRAD® Imaging Bulk Package Transfer Spike
- K252891 — MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)
- K250893 — Ball Joint Guide Array (66295)
- K200280 — MEDRAD Imaging Bulk Package Transfer Spike
- K192370 — MEDRAD Stellant FLEX CT Injection System with Certegra Workstation
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.