Data / Medical devices / Italy / A.T.S. Applicazione Tecnologie Speciali s.r.l.
A.T.S. Applicazione Tecnologie Speciali s.r.l.: FDA-registered device maker in Torre de Roveri Bergamo, Italy, 4 510(k) clearances
A.T.S. Applicazione Tecnologie Speciali s.r.l. is registered with the FDA (registration 3011347852) in Torre de Roveri Bergamo, Italy. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated April 30, 2025. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3011347852
- Address
- Via Alessandro Volta, 10, Torre de Roveri Bergamo, Italy, 24060
- Owner or operator
- SEDECAL S.A. (9039772)
- Roles
- Manufacturer
- First device listed
- October 21, 2019
- Registered through
- 2026
- Brand names listed
- AMRAD Medical Agility, AMRAD Medical Agility Plus, ARCO FP, ARCO FP-S, Cyberbloc FP, Cyberbloc FP-S, OMNISCOP DReam, OMNISCOP Dream-S and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Image-Intensified Fluoroscopic X-Ray System, Mobile | OXO | 2 | Manufacturer | accessdata.fda.gov |
| Interventional Fluoroscopic X-Ray System | OWB | 2 | Manufacturer | accessdata.fda.gov |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | 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 |
|---|---|---|---|---|---|---|
| April 30, 2025 | K250282 | Persona C HR | OWB | Substantially Equivalent | A.T.S. Applicazione Tecnologie Speciali S.R.L. | accessdata.fda.gov |
| August 13, 2021 | K211777 | ARCO FP-S | OWB | Substantially Equivalent | A.T.S. Applicazione Tecnologie Speciali S.R.L. | accessdata.fda.gov |
| July 9, 2021 | K211542 | PRIMO S | MQB | Substantially Equivalent | A.T.S. Applicazione Tecnologie Speciali S.R.L. | accessdata.fda.gov |
| August 20, 2019 | K182086 | ARCO FP | OWB | Substantially Equivalent | A.T.S. Applicazione Tecnologie Speciali S.R.L. | accessdata.fda.gov |
Compare with other makers
- All makers of Image-Intensified Fluoroscopic X-Ray System, Mobile
- All makers of Interventional Fluoroscopic X-Ray System
- All makers of Solid State X-Ray Imager (Flat Panel/Digital Imager)
Updated April 30, 2025. 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.