# K103700: Essential Mri Patient Monitor

- Pathway: 510(k) (Special)
- Applicant: Invivo Corporation
- Decided: Mar 15, 2011 after 85 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 29 generations back to K941811 (1994). 194 ancestors in all.
No later device cites it as a predicate yet.
0 of 195 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090785: Mri Compatible Patient Monitoring System, Model 865214, Invivo Corp. (2009) Summary page 2.

## Indications for use
The MRI Patient Monitor (Model 865353) is intended to monitor vital signs for patients undergoing MRI procedures. The MRI Patient Monitor (Model 865353) is intended for use by healthcare professionals.

Source page: https://510kreport.com/device/K103700
Methodology: https://510kreport.com/methodology