# K950264: Maglife

- Pathway: 510(k) (Traditional)
- Applicant: Odam
- Decided: Sep 27, 1996 after 613 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K864889 (1987). 2 ancestors in all.
59 later devices descend from it; 2 cite it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K864889: Omni-Trak, Invivo Research Labs, Inc. (1987) Summary page 1.
- K935020: Omni-Trac Modification, Invivo Research, Inc. (1995). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K023195: Maglife C/Maglife C Plus (2003), 57 descendants of its own
- K040915: Magnitude 3150M Mri Patient Monitor, Model 3150M (2004), 56 descendants of its own
- 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

## Indications for use
The MAGLIFE® is a device for monitoring the vital signs of patients who are undergoing a Magnetic Resonance Imaging examination. This device is designed for this special environment where ordinary patient monitoring equipment cannot be used for the following reasons : The magnetic and electric fields present in the vicinity of the MRI can interfere with the proper operation of ordinary monitors. The presence of ferromagnetic materials in an ordinary monitor may influence the homogeneity of the magnetic field and thereby degrade the quality of the image acquired. Some magnetic materials can become dangerous projectiles in the presence of large magnetic fields. The indications for use are identical to the indications for vital signs monitoring of patients not undergoing MRI examinations.

Source page: https://510kreport.com/device/K950264
Methodology: https://510kreport.com/methodology