# K090785: Mri Compatible Patient Monitoring System, Model 865214

- Pathway: 510(k) (Special)
- Applicant: Invivo Corp.
- Decided: Dec 15, 2009 after 267 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 28 generations back to K941811 (1994). 193 ancestors in all.
9 later devices descend from it; 4 cite it directly.
0 of 203 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053462: 3160 Mri Patient Monitoring System, Invivo Corporation (2006) Summary page 3.
- K081937: Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules SPO2  Pulse Oximetry Module, Philips Medizin Systeme Boeblingen GmbH (2008) Summary page 3.

## Most influential descendants
- K124061: Mri Patient Monitoring System (Model 865214) (2013), 4 descendants of its own
- K152330: Expression MR400 MRI Patient Monitoring System (2015), 2 descendants of its own
- K121424: Expression Information Portal (2012), 2 descendants of its own
- K212271: smart-sync (2022), 0 descendants of its own
- K212227: Philips MR Patient Care Portal (2021), 0 descendants of its own

## 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-2810-2020: 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
- Apr 13, 2020 · Class II · Z-2244-2020: The labeling of the Philips Chest Pneumograph does not include a statement indicating that the product contains natural rubber latex.
- Oct 15, 2012 · Class II · Z-0468-2013: Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is recalling the Expression MRI Patient Monitoring System because during transport of the systems cart with a docked Display Con
- Aug 30, 2010 · Not classified · Z-0106-2012: Philips Invivo Corporation of Orlando, FL is recalling their Expression MRI Patient Monitoring System. During transport of the system's cart with a docked Display Controller Unit (DCU), a front caster

## 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/K090785
Methodology: https://510kreport.com/methodology