Data / Medical devices / United States / Smaart Medical Systems, Inc.
Smaart Medical Systems, Inc.: FDA-registered device maker in Dallas, TX, United States, 1 510(k) clearance
Smaart Medical Systems, Inc. is registered with the FDA (registration 3025620599) in Dallas, TX, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated August 12, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3025620599
- Address
- 14330 Midway Road, #118, Dallas, TX, United States, 75244
- Owner or operator
- SMAART Medical Systems, Inc. (10086967)
- Roles
- Manufacturer
- First device listed
- December 27, 2022
- Registered through
- 2026
- Brand names listed
- eVolve PACS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 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 |
|---|---|---|---|---|---|---|
| August 12, 2021 | K211863 | eVolve PACS | LLZ | Substantially Equivalent | Evolve Pacs, Inc. | accessdata.fda.gov |
Compare with other makers
Updated August 12, 2021. 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.