Data / Medical devices / United States / Spectral MD, Inc.
Spectral MD, Inc.: FDA-registered device maker in Dallas, TX, United States, 1 510(k) clearance
Spectral MD, Inc. is registered with the FDA (registration 3011050541) in Dallas, TX, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 21, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3011050541
- Address
- 2515 McKinney Ave Ste 1000, Dallas, TX, United States, 75201
- Owner or operator
- Spectral MD, Inc. (10047254)
- Roles
- Manufacturer, Manufacturer for export
- First device listed
- January 26, 2023
- Registered through
- 2027
- Brand names listed
- DeepView, DeepView AI-Burn, DeepView AI® System, DeepView SnapShot
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment. | SHY | 2 | Manufacturer | accessdata.fda.gov |
| Tape, Camera, Surgical | FXN | 1 | Manufacturer for export | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 21, 2026 | DEN250028 | DeepView AI® System | SHY | Unknown | Spectralmd, Inc. | accessdata.fda.gov |
Compare with other makers
Updated May 21, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.