# K131382: Expression MR200 Mri Patient Monitoring System, Expression IP5 Information Portal

- Pathway: 510(k) (Special)
- Applicant: Invivo Corporation
- Decided: Jul 15, 2013 after 62 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: 5 (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.
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)
- K090785: Mri Compatible Patient Monitoring System, Model 865214, Invivo Corp. (2009) Summary page 2.
- K121424: Expression Information Portal, Invivo Corporation (2012) Summary page 2.

## Recalls of this device
- Jun 18, 2020 · Class II · Z-2812-2020: A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its approved charging station and module charger. When the battery is inserted into a charger bay, the LED i
- Jun 18, 2020 · Class II · Z-2811-2020: A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its approved charging station and module charger. When the battery is inserted into a charger bay, the LED i
- Oct 22, 2014 · Class II · Z-0958-2015: The MR 200 devices failed the initial power up test due to capacitor short and hi-pot testing; possible loss of Patient Monitoring or User/Service Electrical Shock.
- Sep 8, 2014 · Class II · Z-0001-2015: During production, excess metal (aluminum) debris was found stuck to the cling plastic that covers the device's pole assembly. The metallic debris could affect system performance due to the potential 
- Sep 5, 2014 · Class II · Z-0069-2015: Failure to produce the Non-Invasive Blood Pressure (NIBP) Measurement.

## Indications for use
The Expression MR200 MRI Patient Monitoring System (Model MR200) and the Expression IP5 Information Portal (Model IP5) are intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner. The Expression MR200 MRI Patient Monitoring System (Model MR200) and the Expression IP5 Information Portal (Model IP5) are intended for use by healthcare professionals. The Expression MR200 MRI Patient Monitoring System (Model MR200) and the Expression IP35 Information Portal (Model IPS) provide monitoring for the following vital sign parameters: EGG, pulse oximetry (Sp02), non-invasive blood pressure (NIBP), and optionally, carbon dioxide (002).

Source page: https://510kreport.com/device/K131382
Methodology: https://510kreport.com/methodology