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510(k) K242752

MRidium 3870 MRI Infusion Pump System (3870) by Iradimed Corporation — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 2025
Date Received
September 12, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

Other clearances by Iradimed Corporation

  • K180903 — 3880 MRI Patient Monitoring System (March 29, 2019)
  • K182900 — 3880 MRI Patient Monitoring System (December 14, 2018)
  • K172200 — 3880 MRI Patient Monitoring System (October 25, 2017)
  • K143369 — MRidium 3860+ MRI infusion Pump/ Monitoring System (December 15, 2016)
  • K090087 — MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM (April 7, 2009)
  • K050301 — MRIDIUM 3850 MRI PUMP SYSTEM (March 24, 2005)

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