Ray 1

Basic Information

• Brand Name: Ray 1
• Primary DI: 00627987231151
• Version / Model: SV403
• Company Name: Swift Medical Inc
• Labeler DUNS: 202686960
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-04-18
• Public Version: 1
• Public Version Date: 2022-04-26
• Public Version Status: New
• Public Device Record Key: a73c0797-87d6-4092-b04e-4d1786f7f6ca

Device 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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QCR	Wound Autofluorescence Imaging Device	General, Plastic Surgery	878.4165	1

GMDN Terms

Code	Name	Definition	Implantable	Status
40803	Infrared thermography system	A system using infrared photography or other infrared detection techniques to produce images or graphical representations of the distribution of body surface temperature for the purpose of diagnosing and assessing various conditions and disease states. Also referred to as a thermography scanner. This system typically consists of a camera display unit that includes a scanning-condensing optical system, infrared detector, an operator's console, photographic cameras, black-body phantom, electronic or computerized controls, software and an image display and analysis units.	No	Active
63176	Fluorescence wound imaging unit	A hand-held, electrically-powered device designed to use violet light illumination and imaging to visualize fluorescent bacteria within/around a wound to assist with wound care protocols and documentation. It includes a violet light(s) for wound illumination and fluorescence, lens, display screen, and includes video/image capture technology.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00627987231151	GS1