DeepView AI® System is an AI-enabled medical device from spectralmd, inc. that the U.S. FDA granted through De Novo DEN250028 on May 21, 2026. Its lead review panel is General and Plastic Surgery and its primary product code is SHY (Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment.).
See also all FDA AI clearances in 2026.
Key facts
| Submission number | DEN250028 |
|---|---|
| Pathway | De Novo |
| Date of final decision | |
| Company (FDA list) | spectralmd, inc. |
| Lead review panel | General and Plastic Surgery |
| Primary product code | SHY — Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment. |
| Applicant (openFDA) | Spectralmd, Inc. |
| Applicant location | Dallas, TX, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 878.1840 |
| Decision code | DENG |
| Submission type | Direct |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
De Novo is the pathway for novel low-to-moderate-risk devices with no predicate. A granted De Novo creates a new device classification that later devices can use as a predicate. DeepView AI® System went through this pathway (DEN250028).
openFDA lists it as a Class 2 device under 21 CFR 878.1840. Class II devices are moderate risk and are subject to general and special controls.
Product code SHY covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. spectralmd, inc. has 2 AI-enabled devices on the list, and the General and Plastic Surgery panel accounts for 9 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.