SnapshotNIR
SnapshotNIR is a non-invasive tissue oxygenation system that uses multispectral imaging across a two-dimensional scanned area. It reports approximate oxygen saturation and hemoglobin…
SnapshotNIR is a non-invasive tissue oxygenation system that uses multispectral imaging across a two-dimensional scanned area. It reports approximate oxygen saturation and hemoglobin measurements for superficial tissue and presents tissue oxygenation as a color-coded image.
The cleared model is KD204. The filing describes a camera with a light source and touchscreen computer, alongside a recharger and reference card. Measurements may be reported for selected tissue regions, while images show oxygenation across the scanned surface.
Listed Item
Tissue oxygenation imaging device
Imaging and Measurements
The filing identifies healthcare professionals as users and describes the device as a tissue oximeter. Its outputs include approximate StO2, oxyhemoglobin (HbO2) and deoxyhemoglobin (Hb) values. A reference card calibrates the camera, and the recharger is used to recharge it.
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (2), Sichuan (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Jiangyin Sinbon Electronics Co Ltd | Jiangyin | Jiangsu | Contract manufacturer | 13 |
| Measurement Specialties Chengdu | Chengdu | Sichuan | Contract manufacturer | 3 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | Kent Imaging Inc, Canada |
|---|---|
| FDA product code | MUD |
| Device type | Oximeter, Tissue Saturation |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2700 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K201976 |
| Record published | 2024-04-05 |
| Record revised | 2026-07-17 (version 2) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KD205 | In distribution | |
| KD204 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Invos | Covidien LP | 54 |
| Nonin | Nonin Medical, Inc. | 30 |
| Fore-Sight Elite® | Cas Medical Systems, Inc. | 12 |
| Fore-Sight® | Cas Medical Systems, Inc. | 9 |
| ForeSight | Edwards Lifesciences Technology Sarl | 7 |
| Spectros T-Stat | Spectros Corporation | 7 |
| Component Neuromonitoring System | Moberg Research, Inc. | 6 |
| HyperView | Hypermed Imaging, Inc. | 6 |
| O3 | Masimo Corporation | 5 |
| Mespere | Mespere Lifesciences Inc. | 3 |
| Moor Instruments Ltd | Moor Instruments Ltd. | 2 |
| T.Ox SS Sensor | Vioptix, Inc. | 1 |
Showing 12 of 30. All products under Oximeter, Tissue Saturation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K240601 | 2024-04-02 |
| K201976 | 2020-11-10 |
| K163070 | 2017-05-05 |
| K113507 | 2012-08-08 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Kent Imaging Inc | 510(k) number | 2023-10-30 | Class II | Nonconforming Material/Component | Tissue oxygenation measurement system touchscreens may be unresponsive, which may prevent the viewing of oxygenation images. | 57 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.