Home GUDID 00860009533615 Spectral AI
Primary DI 00860009533615
Brand Spectral AI
Company Spectral Md, Inc.
Model DeepView AI System
Catalog number 12001
Device description AI-Based Wound Assessment and Imaging System Additional Catalog Numbers: 12002
Published 2026-08-17
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name SHY Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment.
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class SHY Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment.
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860009533615 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00860009533615 00860009533615 860009533615 0860009533615
GMDN Terms# Term, Definition table Term Definition Wound management image-analysis software An 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.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 0 0 Handling Environment Humidity 0 0 Handling Environment Temperature 0 0 Special Storage Condition, Specify 0 0 Do not use if package is damaged Special Storage Condition, Specify 0 0 Fragile; handle with care Special Storage Condition, Specify 0 0 Keep away from direct sunlight Special Storage Condition, Specify 0 0 Keep Dry Storage Environment Atmospheric Pressure 0 0 Storage Environment Humidity 0 0 Storage Environment Temperature 0 0
Regulatory Flags# DUNS number 829852339 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false 
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