# K113507: Kent Camera

- Pathway: 510(k) (Traditional)
- Applicant: Kent Imaging, Inc.
- Decided: Aug 8, 2012 after 254 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.
3 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061848: Hyperspectral Tissue Oxygenation Measurement System, Model Oxy VU1, Hypermed, Inc. (2006) Summary page 1.
- K073656: Oxyvu -1 Hyperspectral Tissue Oxygenation (Hto) Measurement System, Hypermed, Inc. (2008) Summary page 1.

## Most influential descendants
- K163070: Kent Camera (2017), 1 descendant of its own
- K201976: SnapshotNIR (2020), 0 descendants of its own
- K171245: Presygen/si-1 (2018), 0 descendants of its own

## Indications for use
The Kent Camera is intended for use by healthcare professionals as a non-invasive tissue oxygenation measurement system that reports an approximate value of: * oxygen saturation (SO2) * oxyhemoglobin level (HbO2), and * deoxyhemoglobin (Hb) level in superficial tissue. The Kent Camera displays two-dimensional color-coded images of tissue oxygenation of the scanned surface and reports multispectral tissue oxygenation measurements for selected tissue regions. The Kent Camera is indicated for use to determine oxygenation levels in superficial tissues for patients with potential circulatory compromise.

Source page: https://510kreport.com/device/K113507
Methodology: https://510kreport.com/methodology