# K132359: Mri Patient Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Invivo Corporation
- Decided: Aug 30, 2013 after 31 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: 30 generations back to K941811 (1994). 195 ancestors in all.
No later device cites it as a predicate yet.
0 of 196 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K124061: Mri Patient Monitoring System (Model 865214), Invivo Corporation (2013) Summary page 2.

## Indications for use
The MRI Patient Monitoring System (Model 865214) is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner. The MRI Patient Monitoring System (Model 865214) is intended for use by healthcare professionals.

Source page: https://510kreport.com/device/K132359
Methodology: https://510kreport.com/methodology