MRidium 3870 MRI Infusion Pump System (3870)— 510(k) K242752
Substantially EquivalentIradimed Corporation
FDA 510(k) clearance K242752 for MRidium 3870 MRI Infusion Pump System (3870), Substantially Equivalent on 2025-05-28. Applicant: Iradimed Corporation.
Clearance details
- Applicant
- Iradimed Corporation
- Product code
- Code FRN
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Winter Springs, FL, US
Adverse events under product code FRN
product code FRN- Death
- 540
- Injury
- 6,178
- Malfunction
- 1,464,165
- Other
- 52
- Total
- 1,470,935
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.