Automated Wound Measurements

Primary DI
00860475000383
Brand
Automated Wound Measurements
Company
EPIC SYSTEMS CORPORATION
Model
1
Published
2025-02-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FXNTape, Camera, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXNTape, Camera, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860475000383PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860475000383008604750003838604750003830860475000383

GMDN Terms#

Term, Definition table
TermDefinition
Wound management image-analysis softwareAn application software program intended to facilitate monitoring and management of a wound during the healing process based primarily on digital images of the wound. When installed on a device with a camera (e.g., hyperspectral imaging camera, smartphone), the software enables image analysis, clinical data collection and sharing, and might assist in assessing wounded tissue viability to support clinical decision making. It may incorporate artificial intelligence (AI)/deep learning algorithms.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
108299124
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850053416002Blood Product Administration Module42025-02-03
00860475000345Blood Product Administration Module22023-06-19
00860475000314Blood Product Administration Module32020-11-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B376KB1000SnapshotGLOKent Imaging IncFXN2025-07-10
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 IncFXN2022-01-04
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