# K152330: Expression MR400 MRI Patient Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Invivo Corporation
- Decided: Dec 23, 2015 after 127 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: 1 (0 Class I)
- 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.
2 later devices descend from it; 2 cite it directly.
0 of 198 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 5.

## Most influential descendants
- K212271: smart-sync (2022), 0 descendants of its own
- K182900: 3880 MRI Patient Monitoring System (2018), 0 descendants of its own

## Recalls of this device
- Feb 20, 2020 · Class II · Z-1616-2020: Menu selections for users to access the oxygen (O2) sensor calibration were changed and not incorporated into the device s Instructions for Use. As a result, the instructions for performing the O2 sen

## Indications for use
The Expression MR400 MRI Patient Monitoring System (Model MR400) is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner. The Expression MR400 MRI Patient Monitoring System (Model MR400) is intended for use by healthcare professionals. The Expression MR400 MRI Patient Monitoring System (Model MR400) provides monitoring for the following vital sign parameters: ECG, pulse oximetry (SpO2), non-invasive blood pressure (NIBP), and optionally, invasive blood pressure (IBP), carbon dioxide (CO2) and respiration rate, anesthetic agents, nitrous oxide (N2O), oxygen (O2), and/or temperature.

Source page: https://510kreport.com/device/K152330
Methodology: https://510kreport.com/methodology