# K240601: SnapshotNIR model KD205

- Pathway: 510(k) (Traditional)
- Applicant: Kent Imaging, Inc.
- Decided: Apr 2, 2024 after 29 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) SnapshotNIR (KD204): named in the summary without a submission number

## Indications for use
SnapshotNIR (KD205) 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 (KD205) displays two-dimensional color-coded images of tissue oxygenation of the scanned surface and reports multispectral tissue oxygenation measurements for selected tissue regions. SnapshotNIR (KD205) is indicated for use to determine oxygenation levels in superficial tissues.

Source page: https://510kreport.com/device/K240601
Methodology: https://510kreport.com/methodology