Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011050541

FEI Number

3011050541

Entity Name

SPECTRAL MD, INC.

City/State/Country

Dallas, TX, US

Establishment Address

2515 McKinney Ave Ste 1000, Dallas, TX 75201, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Spectral MD, Inc. (Owner Number: 10047254)

Owner / Operator Contact Address

2515 McKinney Ave., Suite 1000, Dallas, TX 75201, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

DEN250028

PMA Number

N/A

All Registered Proprietary Names

DeepView AI® System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FXN	Tape, Camera, Surgical	General, Plastic Surgery	Class 1	878.4160	2023-01-26
SHY	Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment.	General, Plastic Surgery	Class 2	878.1840	2026-06-11

Official Correspondent

Trudy Estridge

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Spectral MD, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011050541. Last updated year: 2026. Please use registration number 3011050541 when referencing this establishment in official correspondence.