Data / Medical devices / United States / DGNCT LLC
DGNCT LLC: FDA-registered device maker in Miami, FL, United States, 2 510(k) clearances
DGNCT LLC is registered with the FDA (registration 3025110425) in Miami, FL, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 15, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3025110425
- Address
- 333 Southeast 2nd Avenue 20th Floor, room 563, Miami, FL, United States, 33131
- Owner or operator
- DGNCT LLC (10086595)
- Roles
- Manufacturer
- First device listed
- January 28, 2026
- Registered through
- 2027
- Brand names listed
- Diagnocat, Segmentron Viewer
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Medical Image | MYN | 2 | Manufacturer | accessdata.fda.gov |
| Automated Radiological Image Processing Software | QIH | 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 |
|---|---|---|---|---|---|---|
| January 15, 2026 | K252934 | Diagnocat | MYN | Substantially Equivalent | DGNCT, LLC | accessdata.fda.gov |
| September 9, 2025 | K251072 | Segmentron Viewer | QIH | Substantially Equivalent | DGNCT, LLC | accessdata.fda.gov |
Compare with other makers
Updated January 15, 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.