Ray 1

Primary DI
00627987231151
Brand
Ray 1
Company
Swift Medical Inc
Model
SV403
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.
Published
2022-04-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FXNTape, Camera, Surgical
QJFAutofluorescence Imaging Adjunct Tool For Wounds

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXNTape, Camera, SurgicalGeneral, Plastic Surgery1
QJFAutofluorescence Imaging Adjunct Tool For WoundsGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251678000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251678000Swift Ray 1Swift Medical, Inc.2026-02-24QJF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00627987231151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00627987231151006279872311516279872311510627987231151

GMDN Terms#

Term, Definition table
TermDefinition
Infrared thermography systemA 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.

Regulatory Flags#

DUNS number
202686960
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00627987231144Swift VisionSV12021-03-15
00627987231168Sheeted HealX12024-09-10
00627987231120HealX12019-10-04
00627987231090Swift Skin and Wound S12019-10-04
00627987231106PointClickCare Skin and WoundS22019-10-04
00627987231113Healogics Photo+S32019-10-04
00627987231137Medline NE1® WMSS42019-10-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00628110259530MolecuLightDX+ SystemMolecuLight IncFXN2026-07-08
00628110259530MolecuLightDX+ SystemMolecuLight IncQJF2026-07-08
00628110259547Thermal Imaging ModuleMolecuLight IncFXN2026-07-08
00628110259585MolecuLightDX+ Thermal Eco ClipMolecuLight IncFXN2026-07-08
B376KB1000SnapshotGLOKent Imaging IncQJF2025-07-10
B376KB1000SnapshotGLOKent Imaging IncFXN2025-07-10
00860475000383Automated Wound MeasurementsEPIC SYSTEMS CORPORATIONFXN2025-02-03
09420071400010SilhouetteStarARANZ MEDICAL LIMITEDFXN2024-04-03
17290017272716Minuteful for WoundHEALTHY.IO LTDFXN2024-03-01
17290017272877Minuteful for Wound at HomeHEALTHY.IO LTDFXN2024-03-01
00860003459850eKare inSightE-Kare Inc.FXN2022-12-01
17290017272709Minuteful for WoundHEALTHY.IO LTDFXN2022-09-15
17290017272556SPOTHEALTHY.IO LTDFXN2022-01-17
07290017272504SPOTHEALTHY.IO LTDFXN2022-01-17
00628110259325MolecuLight i:X SystemMolecuLight IncQJF2022-01-04
00628110259325MolecuLight i:X SystemMolecuLight IncFXN2022-01-04
00628110259387MolecuLightDX SystemMolecuLight IncQJF2022-01-04
00627987231144Swift VisionSwift Medical IncFXN2021-03-15
17290017272501SPOTHEALTHY.IO LTDFXN2020-08-25
00627987231090Swift Skin and Wound Swift Medical IncFXN2019-10-04
00627987231106PointClickCare Skin and WoundSwift Medical IncFXN2019-10-04
00627987231113Healogics Photo+Swift Medical IncFXN2019-10-04
00627987231137Medline NE1® WMSSwift Medical IncFXN2019-10-04
00850677007143PACS Scan MobileHYLAND LLCFXN2019-08-30
06953825902605Dr.meter®Shenzhen Urion Technology Co., LtdFXN2017-03-29