FDA.reportPublic FDA data

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

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#