# K180903: 3880 MRI Patient Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Iradimed Corporation
- Decided: Mar 29, 2019 after 357 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 20 generations back to K962603 (1997). 147 ancestors in all.
No later device cites it as a predicate yet.
2 of 148 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172200: 3880 MRI Patient Monitoring System, Iradimed Corporation (2017) Summary page 4.
- K050399: Mri Compatible Patient Monitoring System, Model 3160, Invivo Research, Inc. (2005) Summary page 4.
- K053269: Masimo Set Rad-8 Pulse Oximeter, Masimo Corporation (2005) Summary page 4.
- K171121: Masimo Root Monitoring System and Accessories, Masimo Corporation (2017) Summary page 5.

## Indications for use
The IRadimed Corporation’s 3880 MRI Patient Monitoring System is intended to monitor a single patient’s vital signs for patients undergoing Magnetic Resonance Imaging (MRI) procedures. The 3880 MRI Patient Monitoring System is intended for use by healthcare professionals. The 3880 MRI Patient Monitoring System is intended for use in Adult and Pediatric, including Neonatal populations, for monitoring of Electrocardiogram (ECG), Pulse Oximetry (SpO2), Non-Invasive Blood Pressure (NIBP), Temperature, Anesthetic Agents, Respiration, Capnography (CO2), and Oxygen (O2).

Source page: https://510kreport.com/device/K180903
Methodology: https://510kreport.com/methodology