Devices · spectralmd, inc.

DeepView AI® System

spectralmd, inc. is listed for DeepView AI® System (DEN250028). The FDA list gives May 21, 2026 as the date of the final decision. The lead panel is General and Plastic Surgery, and the database link on the FDA list is the De Novo pathway. openFDA describes product code SHY as “Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment.”: A software-aided adjunctive diagnostic device for use by healthcare providers in skin wound assessment uses a software algorithm to analyze optical or other physical properties of a skin wound without direct wound contact and returns characterizing information that may include classification, severity, or healing potential of the skin wound. The device is intended for prescription use by healthcare providers to provide adjunctive information to be used in conjunction with clinical assessment. It is not for use as a standalone diagnostic device. openFDA records this submission’s decision description as “Unknown.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN250028

Official FDA database record

Date of final decision

May 21, 2026

Company on the FDA list

spectralmd, inc.

Lead panel

General and Plastic Surgery

Primary product code

SHY

openFDA device name for the code

Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment.

Device class

2

Regulation number

878.1840

openFDA decision description

Unknown

openFDA decision code

DENG

Statement or summary label

Not returned