Esaote S.p.A.
Sesto Fiorentino Firenze, IT
ESAOTE S.P.A. appears in FDA device records in Sesto Fiorentino Firenze, IT. FDA records list 69 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show 9 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 69FDA records hold 69 510(k) clearances for Esaote S.p.A. between 2003 and 2026. The busiest year on record is 2011, with 7. The most recent is 2026, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 1 |
| 2004 | 4 |
| 2005 | 5 |
| 2006 | 4 |
| 2007 | 1 |
| 2008 | 3 |
| 2009 | 2 |
| 2010 | 2 |
| 2011 | 7 |
| 2012 | 5 |
| 2013 | 4 |
| 2014 | 4 |
| 2015 | 2 |
| 2016 | 6 |
| 2017 | 1 |
| 2018 | 3 |
| 2019 | 4 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 3 |
| 2026 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261331 | I-Genius (100019400) | LNH | Substantially Equivalent | |
| K253288 | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) | IYN | Substantially Equivalent | |
| K260746 | S-scan Open (100001800) | LNH | Substantially Equivalent | |
| K251901 | Magnifico Open (100009900) | LNH | Substantially Equivalent | |
| K253310 | 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30) | IYN | Substantially Equivalent | |
| K243253 | 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70) | IYN | Substantially Equivalent | |
| K241671 | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) | IYN | Substantially Equivalent | |
| K241133 | Magnifico Open (100009900); Magnifico MSK ( 100009910) | LNH | Substantially Equivalent | |
| K230179 | 6440 MyLabX90 | IYN | Substantially Equivalent | |
| K212419 | Magnifico Open, Magnifico MSK | LNH | Substantially Equivalent | |
| K212021 | 6430 MyLabX75, 6430 MyLab XPro75 | IYN | Substantially Equivalent | |
| K192157 | 6450 Ultrasound system | IYN | Substantially Equivalent | |
| K191072 | 7410 Ultrasound System (MyLabSigma) | IYN | Substantially Equivalent | |
| K190989 | 6400 Ultrasound System (MyLabX6, MyLabX7) | IYN | Substantially Equivalent | |
| K183685 | O-Scan | LNH | Substantially Equivalent | |
| K183191 | 6420 Ultrasound System | IYN | Substantially Equivalent | |
| K180592 | G-scan Brio | LNH | Substantially Equivalent | |
| K173291 | 6440 Ultrasound System | IYN | Substantially Equivalent | |
| K163082 | 6200 Ultrasound System and 6250 Ultrasound System | IYN | Substantially Equivalent | |
| K161973 | G-scan Brio, S-scan | LNH | Substantially Equivalent | |
| K162290 | MyLabSix CrystaLine | IYN | Substantially Equivalent | |
| K161359 | 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System | IYN | Substantially Equivalent | |
| K161238 | S-scan | LNH | Substantially Equivalent | |
| K153277 | 6200 Ultrasound System and 6250 Ultrasound System | IYN | Substantially Equivalent | |
| K153039 | MRI Dynamic Analysis Plus | LNH | Substantially Equivalent | |
| K151668 | S-scan | LNH | Substantially Equivalent | |
| K142421 | G-scan Brio | LNH | Substantially Equivalent | |
| K142077 | MYLABGAMMA | IYN | Substantially Equivalent | |
| K142008 | MYLABSEVEN, MYLABALPHA | IYN | Substantially Equivalent | |
| K140677 | MYLABSSOGNO | IYN | Substantially Equivalent | |
| K133905 | 6200 / 6250 ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K133490 | G-SCAN BRIO | LNH | Substantially Equivalent | |
| K131996 | S-SCAN | LNH | Substantially Equivalent | |
| K132466 | MYLABSEVEN 6400, MYLABALPHA 7400 | IYN | Substantially Equivalent | |
| K132231 | MYLABSEVEN, MYLABALPHA | IYN | Substantially Equivalent | |
| K120288 | ORTHOCAD SOFTWARE OPTION | LLZ | Substantially Equivalent | |
| K122006 | G-SCAN BRIO | LNH | Substantially Equivalent | |
| K121650 | S-SCAN | LNH | Substantially Equivalent | |
| K121384 | MYLABSOGNO | IYN | Substantially Equivalent | |
| K120748 | SPEEDUP SOFTWARE OPTION | LNH | Substantially Equivalent | |
| K111302 | MYLABSEVEN, MYLABALPHA | IYN | Substantially Equivalent | |
| K111803 | G-SCAN | LNH | Substantially Equivalent | |
| K110688 | MYLABGOLD | IYO | Substantially Equivalent | |
| K110802 | A-CHANNELS LUMBAT SPINE COILS 17; 4-CHANNELS LUMBAR SPINE COILS 18 | LNH | Substantially Equivalent | |
| K110373 | TEMPOROMANIBULAR COIL 15 | MOS | Substantially Equivalent | |
| K110238 | G-SCAN | LNH | Substantially Equivalent | |
| K103152 | 6250 ULTRASOUND SYTEMS | IYN | Substantially Equivalent | |
| K100931 | MYLABTWICE, MODEL 6200 | IYN | Substantially Equivalent | |
| K100670 | S-SCAN, MODEL 9800020010 | MOS | Substantially Equivalent | |
| K092469 | O-SCAN MR SYSTEM | LNH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3012981490 | 3012981490 | ESAOTE S.P.A. | Via degli Olmi 11, Sesto Fiorentino Firenze 50019 IT | 2026 | |
| 8043485 | 3002806926 | ESAOTE S.P.A. | Via Multedo di Pegli 2/E, GENOVA Liguria 16155 IT | 2026 | |
| 9611125 | 3002806925 | ESAOTE S.P.A. | VIA DI CACIOLLE 15, FLORENCE Firenze 50127 IT | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- QIHAutomated Radiological Image Processing Software
- MOSCoil, Magnetic Resonance, Specialty
- LLZSystem, Image Processing, Radiological
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- LNHSystem, Nuclear Magnetic Resonance Imaging
- ITXTransducer, Ultrasonic, Diagnostic
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1490-2026 | 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. | Class II | Completed | |
| Z-3053-2020 | AC/DC POWER SUPPLY for 7400, Part Number 151004301, XP Power Model Number AHM180PS19-XE1057, AC/DC Adapter associated with the following portable ultrasound diagnostic systems: The AC/DC adapter is intended for use with the following portable ultrasound systems: MyLabAlpha (101740000) MyLabGamma (101741000) MyLabOmega (101740004) MyLabSigma (101741004) MyLabSigma elite (101741007) MyLabAlphaVET (101740001) MyLabGammaVET (101741001) MyLabDelta (100743000) MyLabDeltaVET (100743001) MyLabOmegaVET (101740005) MyLabSigmaVET (101741005) | The AC/DC adapter (power supply) of the portable ultrasound systems listed below that may result in the connector heating up, generating smoke and melting. This condition is caused by the mechanical stress of the connection between the AC/DC power adapter and the mains cable over the time of use. | Class II | Terminated | |
| Z-3052-2020 | AC/DC POWER SUPPLY for 7400, Part Number 151004300, XP Power Model Number AHM180PS19-XE0338, AC/DC Adapter associated with the following portable ultrasound diagnostic systems: The AC/DC adapter is intended for use with the following portable ultrasound systems: MyLabAlpha (101740000) MyLabGamma (101741000) MyLabOmega (101740004) MyLabSigma (101741004) MyLabSigma elite (101741007) MyLabAlphaVET (101740001) MyLabGammaVET (101741001) MyLabDelta (100743000) MyLabDeltaVET (100743001) MyLabOmegaVET (101740005) MyLabSigmaVET (101741005) | The AC/DC adapter (power supply) of the portable ultrasound systems listed below that may result in the connector heating up, generating smoke and melting. This condition is caused by the mechanical stress of the connection between the AC/DC power adapter and the mains cable over the time of use. | Class II | Terminated | |
| Z-0206-2019 | MyLab Seven, Model 6400 | 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 one minute of continuous operations. The patient may experience discomfort, reddening of epidermis and/or mild pain. To date, no patient injury has been reported with regards to this issue. | Class II | Terminated | |
| Z-0205-2019 | MyLab Gamma, Model 7410 | 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 one minute of continuous operations. The patient may experience discomfort, reddening of epidermis and/or mild pain. To date, no patient injury has been reported with regards to this issue. | Class II | Terminated | |
| Z-0204-2019 | 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 one minute of continuous operations. The patient may experience discomfort, reddening of epidermis and/or mild pain. To date, no patient injury has been reported with regards to this issue. | Class II | Terminated | |
| Z-1138-2018 | MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; Probes: BL433, C 18, CA541, EC1123, EC123, IH 618, IOT332, IOT342, L 415, LA332E, LA435, LA523, LA533, SI2C41, SL2325, TRT33 | The ultrasound system used in certain settings may result in overheating of the ultrasound probe head. | Class II | Terminated | |
| Z-1137-2018 | 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. | Class II | Terminated | |
| Z-2124-2016 | 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. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain