# K201976: SnapshotNIR

- Pathway: 510(k) (Traditional)
- Applicant: Kent Imaging
- Decided: Nov 10, 2020 after 117 days
- Product code: MUD (Oximeter, Tissue Saturation)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K963903 (1998). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163070: Kent Camera, Kent Imaging, Inc. (2017) Summary page 4.

## Recalls of this device
- Oct 30, 2023 · Class II · Z-0789-2024: Tissue oxygenation measurement system touchscreens may be unresponsive, which may prevent the viewing of oxygenation images.

## Indications for use
SnapshotNIR is intended for use by healthcare professionals as a non-invasive tissue oxygenation measurement system that reports an approximate value of: - oxygen saturation (St02), - relative oxyhemogoblin level (Hb02), and - relative deoxyhemoglobin (Hb) level in superficial tissue. SnapshotNIR displays two-dimensional color-coded images of tissue oxygenation of the scanned surface and reports multispectral tissue oxygenation measurements for selected tissue regions. SnapshotNIR is indicated for use to determine oxygenation levels in superficial tissues.

Source page: https://510kreport.com/device/K201976
Methodology: https://510kreport.com/methodology