# K161237: HyperView Hyperspectral Tissue Oxygenation Measurement System

- Pathway: 510(k) (Traditional)
- Applicant: Hypermed Imaging, Inc.
- Decided: Dec 16, 2016 after 228 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.
No later device cites it as a predicate yet.
0 of 8 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 5.

## Indications for use
The HyperView™ Hyperspectral Tissue Oxygenation Measurement System is intended for use by physicians/healthcare professionals as a noninvasive tissue oxygenation measurement system that reports an approximate value of: * oxygen saturation (O2Sat), * oxyhemoglobin level (Oxy), and * deoxyhemoglobin (Deoxy) level in superficial tissue. The HyperView™ 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 HyperView™ system is indicated for use to determine oxygenation levels in superficial tissues for patients with potential circulatory compromise.

Source page: https://510kreport.com/device/K161237
Methodology: https://510kreport.com/methodology