De Novo · Granted
GrantedDeepView AI® System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectralmd, Inc. · SHY Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment.
Granted on May 21, 2026 as a new device type through De Novo after a 328-day review.
- Decided
- May 21, 2026
- Review
- 328 days
- Class
- Class II
- Product code
- SHY
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in SHY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All SHY devicesSHY Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment.: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · SHY
1so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · SHY
Too few SHY 510(k)s in any year since 2007 to give a median.
Recalls per year · SHY
No recall names SHY since 2007.
Adverse event reports per year · SHY
No MAUDE report names SHY since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (150 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN250028 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN250028: DeepView AI® System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN250028
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026