Device typeWound 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.
FDA categorySoftware-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment.
Device ID00860009533615
Catalog number12001
AvailabilityPrescription
MRI safetyMR Unsafe