# K050399: Mri Compatible Patient Monitoring System, Model 3160

- Pathway: 510(k) (Traditional)
- Applicant: Invivo Research, Inc.
- Decided: Aug 26, 2005 after 191 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: 4 generations back to K864889 (1987). 17 ancestors in all.
55 later devices descend from it; 2 cite it directly.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040915: Magnitude 3150M Mri Patient Monitor, Model 3150M, Invivo Research, Inc. (2004) Summary page 2.
- K041918: Integrated Patient Monitoring System, Invivo Research, Inc. (2004) Summary page 2.

## Most influential descendants
- 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
- K103764: Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable Cardiac Monitor, Model 9528 (2011), 26 descendants of its own

## Indications for use
The 3160 MRI Patient Monitoring System is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner. The 3160 MRI Patient Monitoring System is intended for use by health care professionals.

Source page: https://510kreport.com/device/K050399
Methodology: https://510kreport.com/methodology