# K212227: Philips MR Patient Care Portal

- Pathway: 510(k) (Traditional)
- Applicant: Invivo Corporation
- Decided: Sep 30, 2021 after 76 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.
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)
- K121424: Expression Information Portal, Invivo Corporation (2012) Summary page 4.

## Recalls of this device
- Sep 6, 2022 · Class II · Z-0004-2023: Device may intermittently fail to produce audio. Turning the unit off and on does not resolve the issue; disconnecting and reconnecting to AC power does not reliably resolve the issue.

## Indications for use
The MR Patient Care Portal 5000 is intended for use by healthcare professionals. The device is indicated for use to monitor vital signs of patients undergoing MRI procedures including ECG, pulse oximetry (SpO2), non-invasive blood pressure (NIBP), and optionally, invasive pressure (IP), carbon dioxide (CO2) and respiration rate, anesthetic agents, nitrous oxide (N2O), oxygen (O2), and/or temperature based on the configurations of the host patient monitor with which the MR Patient Care Portal 5000 is wirelessly communicating. The target patient population includes adult, pediatric, and neonatal patients that require monitoring during MRI procedures.

Source page: https://510kreport.com/device/K212227
Methodology: https://510kreport.com/methodology