# K181623: Clarifi Imaging System

- Pathway: 510(k) (Special)
- Applicant: Modulated Imaging, Inc.
- Decided: Jul 19, 2018 after 29 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: 8 generations back to K963903 (1998). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153426: Ox-Imager CS, Modulated Imaging, Inc. (2016) Summary page 4.

## Most influential descendants
- K254129: Spectrum-2 (2026), 0 descendants of its own

## Indications for use
The Clarifi™ Imaging System is indicated for use to determine oxygenation levels in superficial tissues for patients with potential circulatory compromise.

Source page: https://510kreport.com/device/K181623
Methodology: https://510kreport.com/methodology