Data / Medical devices / United States / Esaote North America, Inc
Esaote North America, Inc: FDA-registered device maker in Fishers, IN, United States, 37 510(k) clearances
Esaote North America, Inc is registered with the FDA (registration 1826555) in Fishers, IN, United States. It lists 6 device types. The FDA files 37 510(k) clearances under its listings, the newest dated July 31, 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
- 1826555
- Address
- 11907 Exit Five Parkway, Fishers, IN, United States, 46037
- Owner or operator
- ESAOTE S.P.A. (8021005)
- Roles
- Complaint file establishment
- First device listed
- June 11, 2010
- Registered through
- 2026
- Brand names listed
- 3Viseon, 6200 Ultrasound System, 6250 Ultrasound System, 6400 Model, 6420, 6425, 6430 US System, 6440 Ultrasound System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Complaint file establishment | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Complaint file establishment | accessdata.fda.gov |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | 2 | Complaint file establishment | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Complaint file establishment | accessdata.fda.gov |
| System, Nuclear Magnetic Resonance Imaging | LNH | 2 | Complaint file establishment | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Complaint file establishment | 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 |
| April 6, 2026 | K253288 | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) | IYN | 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 |
| 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 |
| June 26, 2024 | K241133 | Magnifico Open (100009900); Magnifico MSK ( 100009910) | LNH | 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 |
| February 4, 2022 | K212419 | Magnifico Open, Magnifico MSK | LNH | 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 |
| January 22, 2019 | K183685 | O-Scan | LNH | Substantially Equivalent | Esaote, S.p.A. | accessdata.fda.gov |
| December 4, 2018 | K183191 | 6420 Ultrasound System | IYN | 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 |
| 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 25, 2016 | K161973 | G-scan Brio, S-scan | LNH | 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 |
| January 8, 2016 | K153039 | MRI Dynamic Analysis Plus | LNH | 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 |
| 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 |
| 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 |
| December 23, 2009 | K092469 | O-SCAN MR SYSTEM | LNH | Substantially Equivalent | Esaote, S.p.A. | accessdata.fda.gov |
| January 30, 2009 | K083882 | MYLABFIVE | IYN | Substantially Equivalent | Esaote Europe B.V. | accessdata.fda.gov |
| January 24, 2008 | K072653 | 3VISEON/SURGERY | LLZ | Substantially Equivalent | 3Mensio Medical Imaging BV | 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 |
|---|---|---|---|---|---|---|
| June 26, 2014 | 68648 | Class II | Terminated | Esaote PA230E Transducer A portable and cart base ultrasound system for general and cardiovascular imaging | Using the PA230E transducer with a user-defined setting with the output power to 100% (Max) in 2D-TEI mode focusing at maximum depth, could cause the transducer surface temperature to exceed the maximum allowable limit. | accessdata.fda.gov |
| May 6, 2005 | 32019 | Not yet classified | Terminated | MyLab30CV Ultrasound Imaging System; model 9807300000. | Data may be corrupted upon re-opening archived files. | accessdata.fda.gov |
| January 22, 2003 | 25428 | Not yet classified | Terminated | Biosound Caris Plus Ultrasound System with phased array probes, model 7230. Biosound Megas Ultrasound System with phased array probes, model 7250 | Excessive power output due to a faulty voltage controller. | accessdata.fda.gov |
Compare with other makers
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of System, Imaging, Pulsed Doppler, Ultrasonic
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of System, Nuclear Magnetic Resonance Imaging
- All makers of Automated Radiological Image Processing Software
- 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.