Data / Medical devices / Italy / ASG Superconductors S.p.A.
ASG Superconductors S.p.A.: FDA-registered device maker in Genova, Italy, 2 510(k) clearances
ASG Superconductors S.p.A. is registered with the FDA (registration 3004994584) in Genova, Italy. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated November 26, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3004994584
- Address
- Corso F. M. Perrone 73/r, Genova, Italy, 16152
- Owner or operator
- ASG superconductors S.p.A. (10059415)
- Roles
- Manufacturer
- First device listed
- January 8, 2020
- Registered through
- 2026
- Brand names listed
- MROpen Evo (03-2000-00) v12, MROpen Evo (03-2000-00) v4, MROpen Evo (03-2000-00) v8, MRopen EVO
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Nuclear Magnetic Resonance Imaging | LNH | 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 |
|---|---|---|---|---|---|---|
| November 26, 2024 | K242258 | MROpen Evo (03-2000-00); MROpen Evo (03-4000-00) | LNH | Substantially Equivalent | Asg Superconductors S.P.A. | accessdata.fda.gov |
| December 20, 2019 | K193116 | MRopen EVO | LNH | Substantially Equivalent | Asg Superconductors S.P.A. | accessdata.fda.gov |
Compare with other makers
Updated November 26, 2024. 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.