# Esaote Europe B.V.

- Location (FDA's records): Carmel, IN
- FDA decisions: 7 (2006–2016): 7 510(k) clearances
- Product codes: IYN (4), ITX (1), IYO (1), LLZ (1)
- Predicates its devices cite: 27 (6 its own); citations of its devices by later devices: 12 (6 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Esaote, S.p.A.: 11 (https://510kreport.com/company/esaote)
- Pie Medical: 5 (https://510kreport.com/company/pie-medical)
- Sonosite,Inc.: 2 (https://510kreport.com/company/sonosite)
- Biosound Esaote, Inc.: 1 (https://510kreport.com/company/biosound-esaote)
- Sonometric Health, LLC: 1 (https://510kreport.com/company/sonometric-health)
- Advanced Technology Laboratories, Inc.: 1 (https://510kreport.com/company/advanced-technology-laboratories)

## Firms that cite its devices most
- Esaote, S.p.A.: 6 (https://510kreport.com/company/esaote)

## Its most-cited devices
- K141486: Mylabsix Ultrasound System (2014), cited by 4
- K101605: Mylabone Ultrasound System (2010), cited by 3
- K083882: Mylabfive (2009), cited by 2
- K161168: MyLabSix Ultrasound System (2016), cited by 1
- K070903: MYLAB40 (2007), cited by 1
- K061755: MYLAB15/20 New Indications Ultrasound System (2006), cited by 1

## Recent decisions
- K161168: MyLabSix Ultrasound System (Sep 2, 2016)
- K141486: Mylabsix Ultrasound System (Jul 11, 2014)
- K101605: Mylabone Ultrasound System (Aug 31, 2010)
- K083882: Mylabfive (Jan 30, 2009)
- K070903: MYLAB40 (Jul 2, 2007)
- K062598: Imt.Lab Software (Oct 31, 2006)
- K061755: MYLAB15/20 New Indications Ultrasound System (Aug 7, 2006)

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