# K061848: Hyperspectral Tissue Oxygenation Measurement System, Model Oxy VU1

- Pathway: 510(k) (Traditional)
- Applicant: Hypermed, Inc.
- Decided: Nov 8, 2006 after 131 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: 5 generations back to K963903 (1998). 5 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053618: Inspectra Tissue Spectrometer System, Model 325, Hutchinson Technology, Inc. (2006) Summary page 1.
- K042020: Spectra Tissue Spectrometer System (Inspectra), Hutchinson Technology, Inc. (2004) Summary page 1.
- K023938: Modification to Inspectra Tissue Spectrometer System, Model 325, Hutchinson Technology, Inc. (2002) Summary page 1.
- K012759: Inspectra Tissue Spectrometer System (Inspectra), Model 325, Hutchinson Technology, Inc. (2002) Summary page 1.

## Most influential descendants
- K073656: Oxyvu -1 Hyperspectral Tissue Oxygenation (Hto) Measurement System (2008), 8 descendants of its own
- K113507: Kent Camera (2012), 3 descendants of its own
- K153426: Ox-Imager CS (2016), 2 descendants of its own
- K181623: Clarifi Imaging System (2018), 1 descendant of its own
- K163070: Kent Camera (2017), 1 descendant of its own

## Indications for use
The OxyVu-1 Hyperspectral Tissue Oxygenation (HTO) Measurement System is intended for use by healthcare professionals as a non-invasive tissue oxygenation measurement system that reports an approximate value of: · oxygen saturation (HT-Sat), * oxyhemoglobin level (HT-Oxy), and * deoxyhemoglobin (HT-Deoxy) level in superficial tissue. The OxyVu- I system displays two-dimensional color-coded images of tissue oxygenation of the scanned surface and reports hyperspectral tissue oxygenation measurements for selected tissue regions. The OxyVu- 1 system is indicated for use to determine oxygenation levels in superficial tissues for patients with potential circulatory compromise.

Source page: https://510kreport.com/device/K061848
Methodology: https://510kreport.com/methodology