# K190334: MIMOSA Imager

- Pathway: 510(k) (Traditional)
- Applicant: Mimosa Diagnostics, Inc.
- Decided: Nov 1, 2019 after 260 days
- Product code: MUD (Oximeter, Tissue Saturation)
- 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: 4 generations back to K963903 (1998). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042657: Vioptix Odissey Tissue Oximeter Tissue Oximeter, Model Oxy-2, Vioptix, Inc. (2005) Summary page 4.

## Indications for use
The MIMOSA Imager is intended to non-invasively estimate the spatial distribution of percent oxygen saturation (StO2) in a volume of tissue. This is performed in medical environments including physician offices, hospitals, ambulatory care and Emergency Medical Services. The MIMOSA Imager is indicated for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation.

Source page: https://510kreport.com/device/K190334
Methodology: https://510kreport.com/methodology