Not Cleared Direct

DeepView AI® System (DEN250028) - FDA 510(k) Clearance

DEN250028 · Spectralmd, Inc. · General & Plastic Surgery device
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May 2026
Decision
328d
Days
-
Risk

DEN250028 is an FDA 510(k) submission (not cleared) for the DeepView AI® System.

Submitted by Spectralmd, Inc. (Dallas, US). The FDA issued a Not Cleared (DENG) decision on May 21, 2026 after a review of 328 days.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 328 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Spectralmd, Inc. devices

Submission Details

510(k) Number DEN250028 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received June 27, 2025
Decision Date May 21, 2026
Days to Decision 328 days
Submission Type Direct
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
213d slower than avg
Panel avg: 115d · This submission: 328d
Pathway characteristics

Device Classification

Product Code SHY
Device Class -