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510(k) K252891

MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2) by Bayer Medical Care, Inc. — Product Code DXT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 2026
Date Received
September 11, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Injector And Syringe, Angiographic
Device Class
Class II
Regulation Number
870.1650
Review Panel
HO
Submission Type

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  • K182273 — MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stell (November 1, 2018)
  • K182276 — MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit (November 1, 2018)
  • K173773 — MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stell (August 17, 2018)
  • K143538 — MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit (August 14, 2015)

Other clearances for product code DXT

  • K251788 — Extension tube (March 5, 2026)
  • K244038 — High Pressure Tubing (September 5, 2025)
  • K242143 — Angiography Injector (December 23, 2024)
  • K242212 — Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit) (August 27, 2024)
  • K241109 — Single-use Sterile High-pressure Angiographic Syringes and Accessories (August 22, 2024)
  • K230668 — Disposable High-pressure Extension Lines (June 14, 2024)
  • K232388 — High Pressure Tubing (November 21, 2023)
  • K211564 — Sterile High-pressure Angiographic Syringes for Single-use (October 19, 2021)
  • K203004 — ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System (December 17, 2020)
  • K201395 — Sterile High-pressure Angiographic Syringes for single-use (October 28, 2020)