# Esaote, S.p.A.

- Location (FDA's records): Indianpolis, IN
- FDA decisions: 69 (2003–2026): 69 510(k) clearances
- Names in FDA's records: Esaote, S.p.A. (68); Esaote (1)
- Product codes: IYN (34), LNH (28), MOS (4), IYO (2), LLZ (1)
- 510(k) review time since 2016: median 81 days, against 105 for FDA's reviews in the same codes and years (13 of 25 faster)
- Predicates its devices cite: 215 (138 its own); citations of its devices by later devices: 157 (138 its own)
- Recalls linked to its devices: 14 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Biosound Esaote, Inc.: 26 (https://510kreport.com/company/biosound-esaote)
- Esaote Europe B.V.: 6 (https://510kreport.com/company/esaote-europe)
- Brainlab AG: 5 (https://510kreport.com/company/brainlab)
- Siemens Medical Solutions USA, Inc.: 4 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Hitachi Medical Systems America, Inc.: 4 (https://510kreport.com/company/hitachi-medical-systems-america)
- Siemens Medical Solutions: 3 (https://510kreport.com/company/siemens-medical-solutions)
- Aloka Co., Ltd.: 3 (https://510kreport.com/company/aloka)
- Usa Instruments, Inc.: 2 (https://510kreport.com/company/usa-instruments)

## Firms that cite its devices most
- Esaote Europe B.V.: 11 (https://510kreport.com/company/esaote-europe)
- Medcom GmbH: 1 (https://510kreport.com/company/medcom)
- Panasonic Healthcare Co., Ltd.: 1 (https://510kreport.com/company/panasonic-healthcare)
- GE Medical Systems: 1 (https://510kreport.com/company/ge-medical-systems)
- Paramed S.R.L.: 1 (https://510kreport.com/company/paramed)
- Supersonic Imagine: 1 (https://510kreport.com/company/supersonic-imagine)
- Navigant Consulting - on Behalf of Esaote S.P.A.: 1 (https://510kreport.com/company/navigant-consulting-on-behalf-of-esaote)
- Jiangsu Magspin Instrument Co.,Ltd: 1 (https://510kreport.com/company/jiangsu-magspin-instrument)

## Its most-cited devices
- K060827: MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350, 6150, 6100 (2006), cited by 9
- K081794: Model 7340 Ultrasound System (2008), cited by 9
- K091009: MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60, Model 6150 (2009), cited by 7
- K080968: S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan Opera (2008), cited by 7
- K052805: MYLAB30, 50 and 70 Systems Upgrade, Models 7300, 7350, 6150 (2005), cited by 7
- K040596: Ultrasound Imaging System, Model 7300 (2004), cited by 6

## Recent decisions
- K261331: I-Genius (100019400) (Jul 31, 2026)
- K253288: 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) (Apr 6, 2026)
- K260746: S-scan Open (100001800) (Mar 27, 2026)
- K251901: Magnifico Open (100009900) (Mar 5, 2026)
- K253310: 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30) (Nov 25, 2025)
- K243253: 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70) (Jun 18, 2025)
- K241671: 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) (May 16, 2025)
- K241133: Magnifico Open (100009900); Magnifico MSK ( 100009910) (Jun 26, 2024)

Source page: https://510kreport.com/company/esaote