# K182900: 3880 MRI Patient Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Iradimed Corporation
- Decided: Dec 14, 2018 after 59 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: 31 generations back to K941811 (1994). 203 ancestors in all.
No later device cites it as a predicate yet.
0 of 204 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.
- K152330: Expression MR400 MRI Patient Monitoring System, Invivo Corporation (2015) Summary page 4.

## 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), Non-Invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP) and Temperature. The 3880 MRI Patient Monitoring System is also intended for use in Adult and Pediatric, not including Neonatal populations, for monitoring of Pulse Oximetry (SpO2), Anesthetic Agents, Respiration, Capnography (CO2) and Oxygen (O2). The 3880 MRI Patient Monitoring System provides monitoring for three distinct patient types as defined below (Note: Pediatric group excludes Neonates): 1 - Adult (greater than 22 years), 2 - Pediatric (Infant 29 days - 2 years), Child (2 - 12 years), Adolescent (12 - 21 years), 3 - Neonate (28 days).

Source page: https://510kreport.com/device/K182900
Methodology: https://510kreport.com/methodology