# K053462: 3160 Mri Patient Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Invivo Corporation
- Decided: Jan 18, 2006 after 36 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K864889 (1987). 20 ancestors in all.
53 later devices descend from it; 3 cite it directly.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050399: Mri Compatible Patient Monitoring System, Model 3160, Invivo Research, Inc. (2005) Summary page 2.
- 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.
- K040011: Polaris 2004 Capnograph, Oridion, Ltd. (2004) Summary page 2.

## Most influential descendants
- 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
- K132649: Reveal Linq Insertable Cardiac Monitor (2014), 23 descendants of its own

## Recalls of this device
- Sep 23, 2011 · Not classified · Z-0113-2012: Philips Invivo has determined that it is possible for the system's alarm limits and other device settings to spontaneously change without user intervention. This problem is associated with intermitten
- Aug 13, 2008 · Not classified · Z-0971-2009: Battery Failure: The Invivo Lithium Polymer Wireless Module Battery Part Number 9065 and the Lithium Polymer Fiber Optic Module Battery Part Number 9067 is being recalled because the battery, itself, 

## 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/K053462
Methodology: https://510kreport.com/methodology