# K153426: Ox-Imager CS

- Pathway: 510(k) (Traditional)
- Applicant: Modulated Imaging, Inc.
- Decided: Dec 21, 2016 after 392 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: 7 generations back to K963903 (1998). 7 ancestors in all.
2 later devices descend 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)
- K073656: Oxyvu -1 Hyperspectral Tissue Oxygenation (Hto) Measurement System, Hypermed, Inc. (2008) Summary page 4.

## Most influential descendants
- K181623: Clarifi Imaging System (2018), 1 descendant of its own
- K254129: Spectrum-2 (2026), 0 descendants of its own

## Indications for use
The Ox-Imager CS™ is indicated for use to determine oxygenation levels in superficial tissues for patients with potential circulatory compromise.

Source page: https://510kreport.com/device/K153426
Methodology: https://510kreport.com/methodology