Data / Medical devices / United States / DeepX Health Device Operations
DeepX Health Device Operations: FDA-registered device maker in Frisco, TX, United States, 1 510(k) clearance
DeepX Health Device Operations is registered with the FDA (registration 3038715764) in Frisco, TX, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 17, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3038715764
- Address
- 6300 Fm 423 Apt 7105, Frisco, TX, United States, 75036
- Owner or operator
- DeepX Health LLC (10093571)
- Roles
- Manufacturer
- First device listed
- June 4, 2025
- Registered through
- 2026
- Brand names listed
- DermoSight
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Light Based Imaging | PSN | 2 | Manufacturer | 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 17, 2023 | K230448 | DeepX DermoSight Dermatoscope | PSN | Substantially Equivalent | Deepx Health, LLC | accessdata.fda.gov |
Compare with other makers
Updated May 17, 2023. 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.