# K041918: Integrated Patient Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Invivo Research, Inc.
- Decided: Oct 15, 2004 after 91 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: 2 generations back to K832113 (1983). 9 ancestors in all.
56 later devices descend from it; 2 cite it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002030: Omni-Trak 3150/3155A Series Monitor with Anesthetic Agent, Model 3155A Series, Invivo Research, Inc. (2000) Summary page 1.
- K974581: Millennia 3500 Series Monitor with Anthesthetic Agent, Invivo Research, Inc. (1998) Summary page 1.

## Most influential descendants
- K050399: Mri Compatible Patient Monitoring System, Model 3160 (2005), 55 descendants of its own
- K053462: 3160 Mri Patient Monitoring System (2006), 53 descendants of its own
- K071641: Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539) (2007), 40 descendants of its own
- K071655: Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538 (2007), 30 descendants of its own
- K082475: Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac Monitor, Model 9528 (2008), 28 descendants of its own

## Indications for use
The Philips Medical Systems Integrated Patient Monitoring System (IPMS) is intended to monitor the heart rhythm and other vital signs for a patient undergoing an MRI procedure and to provide signals for synchronization for the MRI scanner.

Source page: https://510kreport.com/device/K041918
Methodology: https://510kreport.com/methodology