Data / Medical devices / Turkey / Smart Alfa Teknoloji Sanayi Ve Ticaret Anonim Sirketi
Smart Alfa Teknoloji Sanayi Ve Ticaret Anonim Sirketi: FDA-registered device maker in Ankara, Turkey, 2 510(k) clearances
Smart Alfa Teknoloji Sanayi Ve Ticaret Anonim Sirketi is registered with the FDA (registration 3042158826) in Ankara, Turkey. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 21, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3042158826
- Address
- Universiteler Mah. Ihsan Dogramaci Blv. 17-1 No.109 Ankara, 06800 Turkey, Ankara, Turkey, 06800
- Owner or operator
- SMART ALFA TEKNOLOJI SANAYI VE TICARET ANONIM SIRKETI (10094328)
- Roles
- Manufacturer
- First device listed
- November 24, 2025
- Registered through
- 2026
- Brand names listed
- MSK Go, Nerveblox
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| Ultrasound Guided Nerve Block Assist | QRG | 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 21, 2026 | K260234 | MSK Go | QIH | Substantially Equivalent | Smart Alfa Teknoloji San. Ve Tic. A.S. | accessdata.fda.gov |
| August 15, 2025 | K250818 | Nerveblox | QRG | Substantially Equivalent | Smart Alfa Teknoloji San. Ve Tic. A.S. | 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.