Identity
- Trade Name
- Ray 1 FDA UDI
- Generic Name
- Infrared thermography system FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- SV403 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00627987231151 FDA UDI
- FDA Product Code
- QCR FDA UDI
- GMDN Term
- Infrared thermography system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4165 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Infrared thermography systemFluorescence wound imaging unit
Ray 1 by Swift Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Swift Medical, Inc.
Sources (1)
- FDA UDI a73c0797-87d6-4092-b04e-4d1786f7f6ca 33 fields · synced May 30, 2026