Data / Medical devices / Italy / Esaote S.P.A.
Esaote S.P.A.: FDA-registered device maker in FLORENCE Firenze, Italy, 16 510(k) clearances
Esaote S.P.A. is registered with the FDA (registration 9611125) in FLORENCE Firenze, Italy. It lists 4 device types. The FDA files 16 510(k) clearances under its listings, the newest dated April 6, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9611125
- FEI number
- 3002806925
- Address
- Via Di Caciolle 15, FLORENCE Firenze, Italy, 50127
- Owner or operator
- ESAOTE S.P.A. (8021005)
- Roles
- Manufacturer
- First device listed
- December 3, 2014
- Registered through
- 2026
- Brand names listed
- 6400 Model, 6420, 6425, 6430 US System, 6440 Ultrasound System, 6450 Model, 7348, 7400 model and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | 2 | Manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 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 6, 2026 | K253288 | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) | IYN | Substantially Equivalent | Esaote, S.p.A. | accessdata.fda.gov |
| November 25, 2025 | K253310 | 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30) | IYN | Substantially Equivalent | Esaote, S.p.A. | accessdata.fda.gov |
| June 18, 2025 | K243253 | 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70) | IYN | Substantially Equivalent | Esaote, S.p.A. | accessdata.fda.gov |
| May 16, 2025 | K241671 | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) | IYN | Substantially Equivalent | Esaote, S.p.A. | accessdata.fda.gov |
| November 29, 2023 | K230179 | 6440 MyLabX90 | IYN | Substantially Equivalent | Esaote, S.p.A. | accessdata.fda.gov |
| September 16, 2021 | K212021 | 6430 MyLabX75, 6430 MyLab XPro75 | IYN | Substantially Equivalent | Esaote, S.p.A. | accessdata.fda.gov |
| November 22, 2019 | K192157 | 6450 Ultrasound system | IYN | Substantially Equivalent | Esaote, S.p.A. | accessdata.fda.gov |
| June 10, 2019 | K191072 | 7410 Ultrasound System (MyLabSigma) | IYN | Substantially Equivalent | Esaote, S.p.A. | accessdata.fda.gov |
| May 10, 2019 | K190989 | 6400 Ultrasound System (MyLabX6, MyLabX7) | IYN | Substantially Equivalent | Esaote, S.p.A. | accessdata.fda.gov |
| April 1, 2019 | K190447 | 7400 Ultrasound Systems | IYN | Substantially Equivalent | Navigant Consulting - on Behalf of Esaote S.P.A. | accessdata.fda.gov |
| December 4, 2018 | K183191 | 6420 Ultrasound System | IYN | Substantially Equivalent | Esaote, S.p.A. | accessdata.fda.gov |
| January 12, 2018 | K173291 | 6440 Ultrasound System | IYN | Substantially Equivalent | Esaote, S.p.A. | accessdata.fda.gov |
| March 16, 2017 | K163082 | 6200 Ultrasound System and 6250 Ultrasound System | IYN | Substantially Equivalent | Esaote, S.p.A. | accessdata.fda.gov |
| October 14, 2016 | K162290 | MyLabSix CrystaLine | IYN | Substantially Equivalent | Esaote, S.p.A. | accessdata.fda.gov |
| July 19, 2016 | K161359 | 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System | IYN | Substantially Equivalent | Esaote, S.p.A. | accessdata.fda.gov |
| April 25, 2014 | K140677 | MYLABSSOGNO | IYN | Substantially Equivalent | Esaote, S.p.A. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 6, 2016 | 74391 | Class II | Terminated | Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000) | The device is being recalled because dynamic loading forces from larger patients can fracture the extremity portion of the patient table. Additionally, a weight limit is added to the patient seat for weight-bearing examinations. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of System, Imaging, Pulsed Doppler, Ultrasonic
- All makers of Automated Radiological Image Processing Software
Updated April 6, 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.