# DEN250028: DeepView AI® System

- Pathway: De Novo (Direct)
- Applicant: Spectralmd, Inc.
- Decided: May 21, 2026 after 328 days
- Product code: SHY (Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment.)
- Device class: 2
- Regulation: 21 CFR 878.1840
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The DeepView AI®-Burn software analyzes images obtained using the DeepView AI® System, using artificial intelligence to detect deep burn tissue (deep partial thickness and full thickness) and provides segmentation of specific areas in a burn wound by highlighting areas that are unlikely to heal within 21 days with conservative treatment alone. The absence of a highlighted region on an image indicates the absence of deep burn tissue. The system will calculate wound area measurement and percent total body surface area (TBSA) burn. DeepView AI® System with AI®-Burn software is an aid to physicians in the management of thermal burn wounds and considering various treatment plans. The DeepView AI® System should be used in conjunction with clinical assessment and not as a stand-alone diagnostic device. The device's segmentation contour does not provide definitive delineation of the deep burn margin for precise excision sizing or delineating the precise borders of non-healing tissue.

Source page: https://510kreport.com/device/DEN250028
Methodology: https://510kreport.com/methodology