Ray 1 is a portable hyperspectral imaging tool that allows qualified healthcare professionals, to assess wounds, at the point of care: i) to capture and digitally record images of…
Ray 1 is a portable hyperspectral imaging tool that allows qualified healthcare professionals, to assess wounds, at the point of care: i) to capture and digitally record images of fluorescence emitted from a wound when exposed to excitation light and ii) to capture and digitally record images through measuring surface temperature distribution.
Who Else Makes It
Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Ray 1 | Listed by | Swift Medical, Canada |
| FDA product code | QCR |
| Device type | Wound Autofluorescence Imaging Device |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4165 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-04-18 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
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.