Data / Medical devices / Italy / Esaote S.P.A.
Esaote S.P.A.: FDA-registered device maker in Sesto Fiorentino Firenze, Italy, 24 510(k) clearances
Esaote S.P.A. is registered with the FDA (registration 3012981490) in Sesto Fiorentino Firenze, Italy. It lists 4 device types. The FDA files 24 510(k) clearances under its listings, the newest dated April 6, 2026. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012981490
- Address
- Via degli Olmi 11, Sesto Fiorentino Firenze, Italy, 50019
- Owner or operator
- ESAOTE S.P.A. (8021005)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- June 3, 2011
- Registered through
- 2026
- Brand names listed
- 6200 Ultrasound System, 6250 Ultrasound System, 6400 Model, 6420, 6425, 6430 US System, 6440 Ultrasound System, 6450 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 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Exporter to the US, 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 |
| September 2, 2016 | K161168 | MyLabSix Ultrasound System | IYN | Substantially Equivalent | Esaote Europe B.V. | 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 |
| September 12, 2014 | K142008 | MYLABSEVEN, MYLABALPHA | 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 |
| April 15, 2014 | K133905 | 6200 / 6250 ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Esaote, S.p.A. | accessdata.fda.gov |
| June 2, 2011 | K110688 | MYLABGOLD | IYO | Substantially Equivalent | Esaote | accessdata.fda.gov |
| August 31, 2010 | K101605 | MYLABONE ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Esaote Europe B.V. | accessdata.fda.gov |
| January 30, 2009 | K083882 | MYLABFIVE | IYN | Substantially Equivalent | Esaote Europe B.V. | accessdata.fda.gov |
| July 2, 2007 | K070903 | MYLAB40 | ITX | Substantially Equivalent | Esaote Europe B.V. | accessdata.fda.gov |
| April 25, 2002 | K014168 | AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION OF 3D IMAGING MODE AND MUSCULOSKELETAL INDICATION) | IYN | Substantially Equivalent | Biosound Esaote, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 14, 2025 | 98339 | Class II | Completed | Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038 | A potential weakness has been identified in the probe body, so that, in a specific production batch, liquid may leak from the terminal part of the casing near the cable. | accessdata.fda.gov |
| June 11, 2018 | 81285 | Class II | Terminated | MyLab Alpha, Model 7400 | The probe power monitoring settings have been found to be not appropriate under specific operating conditions when connected to the devices listed below. This issue may result in overheating of the probe head. The probe power monitoring settings may not be effective in specific operating conditions so that the surface of the probe head may overheat in around | accessdata.fda.gov |
| January 3, 2018 | 79547 | Class II | Terminated | MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; PA023E Probe 7.5/10 | The ultrasound system used in certain settings may result in overheating of the ultrasound probe head. | accessdata.fda.gov |
Compare with other makers
- All makers of Automated Radiological Image Processing Software
- All makers of System, Imaging, Pulsed Doppler, Ultrasonic
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of Transducer, Ultrasonic, Diagnostic
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.