Ray 1

GUDID 00627987231151

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.

Swift Medical Inc

Infrared thermography system Infrared thermography system Infrared thermography system Infrared thermography system Infrared thermography system Infrared thermography system Infrared thermography system Infrared thermography system Infrared thermography system Infrared thermography system Infrared thermography system Infrared thermography system Infrared thermography system
Primary Device ID00627987231151
NIH Device Record Keya73c0797-87d6-4092-b04e-4d1786f7f6ca
Commercial Distribution StatusIn Commercial Distribution
Brand NameRay 1
Version Model NumberSV403
Company DUNS202686960
Company NameSwift Medical Inc
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100627987231151 [Primary]

FDA Product Code

QCRWound Autofluorescence Imaging Device

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-26
Device Publish Date2022-04-18

Devices Manufactured by Swift Medical Inc

00627987231151 - Ray 12022-04-26Ray 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.
00627987231151 - Ray 12022-04-26 Ray 1 is a portable hyperspectral imaging tool that allows qualified healthcare professionals, to assess wounds, at the point of
00627987231144 - Swift Vision2021-03-23
00627987231120 - HealX2020-03-23
00627987231090 - Swift Skin and Wound 2019-10-14
00627987231106 - PointClickCare Skin and Wound2019-10-14
00627987231113 - Healogics Photo+2019-10-14
00627987231137 - Medline NE1® WMS2019-10-14

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