FDA.reportPublic FDA data

SPECTRAL MD, INC.

Matched from indexed company URL: Spectral MD, Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30110505413011050541SPECTRAL MD, INC.1N2026-01-012515 McKinney Ave Ste 1000 Dallas TX US 75201

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00860009533615Spectral AI - AI-Based Wound Assessment and Imaging System Additional Catalog Numbers: 12002800-846-4172support@spectralmd.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1734611325578865DEN250028DeepView AI® SystemSHY2026-05-21
1734611963322303

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
SHY12026-05-21

PMN#

GUDID#