# K971840: Omni-Trak Model 3150 Series Patient Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Invivo Research, Inc.
- Decided: Mar 4, 1998 after 289 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
This device is intended for use as a patient vital signs monitor during magnetic resonance imaging (MRI) scans. It is intended to be used by or on the order of a physician or similarly qualified health care professional. This device is intended for use in the hospital environment (MRI, Radiology Clinic, or similar settings). This device is not intended for home use. * This device includes the capability for monitoring the following patient parameters: ECG Heart Rate Pulse Oximetry Non-Invasive Blood Pressure Invasive Blood Pressure End-Tidal Carbon Dioxide / Nitrous Oxide Respiration effort

Source page: https://510kreport.com/device/K971840
Methodology: https://510kreport.com/methodology