3880 MRI Patient Monitoring System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K172200 FDA 510(k)
- FDA Product Code
- MWI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2300 FDA 510(k)
- Regulation Number
- 870.2300 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The 3880 MRI Patient Monitoring System is a non-magnetic vital signs monitor designed for use in the MRI suite. It provides full functionality in a compact package and can be mounted on walls, roll-stands, bed rails, or anesthesia carts, with the ability to be quickly detached for mobility.
This device is used to acquire, process, and display vital sign measurements during patient inter-departmental transport and during MRI exams. It is supplied as a patient monitor system and is FDA 510K cleared. The device is mountable in various locations within the MRI suite for convenient monitoring during patient procedures.
Frequently asked questions
What is the 3880 MRI Patient Monitoring System used for?
The 3880 MRI Patient Monitoring System is designed to acquire, process, and display vital sign measurements during patient inter-departmental transport and during MRI exams. It provides full functionality in a compact package specifically for use in the MRI suite.
How can the 3880 MRI Patient Monitoring System be mounted?
The device can be mounted on walls, roll-stands, bed rails, or anesthesia carts within the MRI suite. It also has the ability to be quickly detached for mobility when needed during patient procedures.
What is the regulatory status of the 3880 MRI Patient Monitoring System?
The 3880 MRI Patient Monitoring System is FDA 510K cleared, with a decision code of SESE (Substantially Equivalent) and was reviewed by the Cardiovascular advisory committee. It received clearance on October 25, 2017.
Is the 3880 MRI Patient Monitoring System suitable for all MRI environments?
Yes, the 3880 is specifically designed as a non-magnetic vital signs monitor for use in MRI suites. Its non-magnetic properties ensure it won't interfere with MRI imaging while providing essential patient monitoring capabilities.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: MRI-Compatible Patient Monitor — IRadimed, IRADIMED 3880 MRI REFERENCE MANUAL Pdf Download, MRI patient monitor - 3880 - IRADIMED CORPORATION - MedicalExpo, Iradimed 3880 MRI Manuals | ManualsLib
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K172200 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Iradimed Corporation
Sources (1)
- FDA 510(k) K172200 24 fields · synced Oct 6, 2026