Data / Medical devices / Italy / Esaote S.P.A.
Esaote S.P.A.: FDA-registered device maker in GENOVA Liguria, Italy, 12 510(k) clearances
Esaote S.P.A. is registered with the FDA (registration 8043485) in GENOVA Liguria, Italy. It lists 2 device types. The FDA files 12 510(k) clearances under its listings, the newest dated July 31, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8043485
- FEI number
- 3002806926
- Address
- Via Multedo di Pegli 2/E, GENOVA Liguria, Italy, 16155
- Owner or operator
- ESAOTE S.P.A. (8021005)
- Roles
- Manufacturer
- First device listed
- June 11, 2010
- Registered through
- 2026
- Brand names listed
- G-Scan Brio, G-Scan Open, G-scan Brio, Head Coil 16, I-Genius, MRI Dynamic Analysis Plus, Magnifico MSK, Magnifico Open and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
| 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 |
|---|---|---|---|---|---|---|
| July 31, 2026 | K261331 | I-Genius (100019400) | LNH | Substantially Equivalent | Esaote, S.p.A. | accessdata.fda.gov |
| March 27, 2026 | K260746 | S-scan Open (100001800) | LNH | Substantially Equivalent | Esaote, S.p.A. | accessdata.fda.gov |
| March 5, 2026 | K251901 | Magnifico Open (100009900) | LNH | Substantially Equivalent | Esaote, S.p.A. | accessdata.fda.gov |
| June 26, 2024 | K241133 | Magnifico Open (100009900); Magnifico MSK ( 100009910) | LNH | Substantially Equivalent | Esaote, S.p.A. | accessdata.fda.gov |
| February 4, 2022 | K212419 | Magnifico Open, Magnifico MSK | LNH | Substantially Equivalent | Esaote, S.p.A. | accessdata.fda.gov |
| January 22, 2019 | K183685 | O-Scan | LNH | Substantially Equivalent | Esaote, S.p.A. | accessdata.fda.gov |
| March 30, 2018 | K180592 | G-scan Brio | LNH | Substantially Equivalent | Esaote, S.p.A. | accessdata.fda.gov |
| October 25, 2016 | K161973 | G-scan Brio, S-scan | LNH | Substantially Equivalent | Esaote, S.p.A. | accessdata.fda.gov |
| January 8, 2016 | K153039 | MRI Dynamic Analysis Plus | LNH | Substantially Equivalent | Esaote, S.p.A. | accessdata.fda.gov |
| September 19, 2012 | K120288 | ORTHOCAD SOFTWARE OPTION | LLZ | Substantially Equivalent | Esaote, S.p.A. | accessdata.fda.gov |
| May 1, 2012 | K120748 | SPEEDUP SOFTWARE OPTION | LNH | Substantially Equivalent | Esaote, S.p.A. | accessdata.fda.gov |
| December 23, 2009 | K092469 | O-SCAN MR SYSTEM | LNH | Substantially Equivalent | Esaote, S.p.A. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Nuclear Magnetic Resonance Imaging
- All makers of System, Image Processing, Radiological
Updated July 31, 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.