General and Plastic Surgery · De Novo · 2026
DeepView AI System
spectralmd, inc.. Granted by FDA on 21 May 2026 under submission DEN250028, product code SHY (software-aided adjunctive diagnostic device for use by healthcare providers in skin wound assessment.). What FDA's record says, in FDA's words.
Device record · DEN250028
- Device. DeepView AI SystemDEVICE
- Company. spectralmd, inc.COMPANY
- Decision. 21 May 2026, De NovoDECISION
- Panel. General and Plastic SurgeryPANEL
- Product code. SHY, Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment.CODE
- Regulation. 21 CFR 878.1840, Class IIREG
- Source. FDA database entry · decision document (5 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA granted it for
The Indications for Use statement, verbatim, from the decision document.
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. DEN250028 - Trudy Estridge Page 2 FDA concludes that this device should be classified into Class II. This order, therefore, classifies the DeepView AI System, and substantially equivalent devices of this generic type, into Class II under the generic name software-aided adjunctive diagnostic device for use by healthcare providers in skin wound assessment. FDA identifies this generic type of device as: Software-aided adjunctive diagnostic device for use by healthcare providers in skin wound assessment. […]
The product code's definition, from FDA's classification record. 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.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsan adjunct to the clinician, not a replacement
- Mentionsdetection or identification of findings
- Mentionsmeasurement or quantification
- Mentionsa diagnostic claim
- Mentionsa statement that it is not for primary diagnosis
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code SHY. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code SHY, in General and Plastic Surgery, from spectralmd, inc., or granted in 2026. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.