# K040915: Magnitude 3150M Mri Patient Monitor, Model 3150M

- Pathway: 510(k) (Traditional)
- Applicant: Invivo Research, Inc.
- Decided: Sep 22, 2004 after 167 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: 3 generations back to K864889 (1987). 14 ancestors in all.
56 later devices descend from it; 2 cite it directly.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974581: Millennia 3500 Series Monitor with Anthesthetic Agent, Invivo Research, Inc. (1998) Summary page 1.
- K923189: Luxtron Model 3100/3101/3102 Multichannel, Luxtron (1994) Summary page 1.
- K023195: Maglife C/Maglife C Plus, Schiller Medical S.A. (2003) 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 Invivo Research Inc. Magnitude TM 3150M MRI Monitor is a device comprised of two separate monitors: the 3150M Monitor, which operates as the base monitor, and the 3155 Monitor, which operates as a Remote Display monitor. The 3150 and 3155 Monitors communicate through a bi-directional radio-link which operates within the MRI area. Both monitors display the patient information, and must be used together for the system to operate. A warning message is displayed if the radio-link is broken. The Invivo Research Inc. Magnitude TM 3150M MRI Monitor is intended for general hospital or clinical use within a magnetic resonance imaging (MRI) area by medical professionals whenever it is required to monitor concentrations of anesthetic gases. The agents monitored include halothane, enflurane, isoflurane, sevoflurane and desflurane. Additionally, this monitor also monitors end-tidal carbon dioxide, nitrous oxide, oxygen gas concentrations, ECG, non-invasive blood pressure, invasive blood pressure and temperature. This device is available for sale only upon the order of a physician or other related licensed medical professional.

Source page: https://510kreport.com/device/K040915
Methodology: https://510kreport.com/methodology