510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN250028Unknown

DeepView AI® System

Spectralmd, Inc., Dallas TX / Direct, Unknown
FDA source (opens on fda.gov)

DEN250028 is the FDA 510(k) clearance record for DeepView AI® System, a class II device, cleared for Spectralmd, Inc. on under FDA product code SHY (Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment.). FDA's definition for product code SHY reads: "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...". FDA records list 3 510(k) clearances for Spectralmd, Inc., from to . As of , FDA records show no recalls naming DEN250028.

Clearance record

Decision date
Received
(328 days to decision)
Product code
SHY Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment.
Regulation
21 CFR 878.1840
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Spectralmd, Inc. 2515 Mckinney Ave. Suite 1000, Dallas TX
Third party review
No

Clearances, product code SHY

Trailing 12 months
1 clearance under product code SHY in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SHY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260