# K172200: 3880 MRI Patient Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Iradimed Corporation
- Decided: Oct 25, 2017 after 96 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: 10 generations back to K946306 (1995). 36 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142032: Mri Patient Monitoring System Tesla M3, Mipm Mammendorfer Institut Fur Physik Und Medizin (2015) Summary page 4.

## Most influential descendants
- K180903: 3880 MRI Patient Monitoring System (2019), 0 descendants of its own
- K182900: 3880 MRI Patient Monitoring System (2018), 0 descendants of its own

## 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), 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 (C0O2), and Oxygen (02). The 3880 MRI Patient Monitoring System provides monitoring for three distinct patient types as defined below (Note: Pediatric group excludes Neonates): Patient Type Age 1 Adult greater than 22 years 2 Pediatric (Includes: Infant, Child and Adolescent) -Adolescent aged 12 through 21 (up to but not including the 22nd birthday) -Child 2 years to less than 12 years -Infant 29 days to less than 2 years 3 Neonate from birth through the first 28 days of life

Source page: https://510kreport.com/device/K172200
Methodology: https://510kreport.com/methodology