Esaote Europe B.V.: FDA clearances and approvals
Esaote Europe B.V. has 7 FDA 510(k) clearances (first 2006, latest 2016), across 4 product codes in 1 review panel. Median 510(k) review time: 60 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 36 |
| 2015 | 0 | — |
| 2016 | 1 | 129 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 4 | 4 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 | 1 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
Review panels
- Radiology (7)
Most recent Esaote Europe B.V. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K161168 | MyLabSix Ultrasound System | IYN | 2016-09-02 | 129 |
| K141486 | MYLABSIX ULTRASOUND SYSTEM | IYN | 2014-07-11 | 36 |
| K101605 | MYLABONE ULTRASOUND SYSTEM | IYN | 2010-08-31 | 84 |
| K083882 | MYLABFIVE | IYN | 2009-01-30 | 32 |
| K070903 | MYLAB40 | ITX | 2007-07-02 | 91 |
| K062598 | IMT.LAB SOFTWARE | LLZ | 2006-10-31 | 60 |
| K061755 | MYLAB15/20 NEW INDICATIONS ULTRASOUND SYSTEM | IYO | 2006-08-07 | 47 |
Recalls
openFDA lists no recalls under a recalling firm named Esaote Europe B.V..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Esaote Europe B.V. have?
Esaote Europe B.V. has 7 FDA 510(k) clearances (first 2006, latest 2016), across 4 product codes in 1 review panel.
How long does FDA take to clear Esaote Europe B.V.'s 510(k)s?
The median time from FDA receipt to decision across Esaote Europe B.V.'s cleared 510(k)s is 60 days.
What devices does Esaote Europe B.V. make?
Its most frequent FDA product codes are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 4); ITX (Transducer, Ultrasonic, Diagnostic, 1); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 1).
Has Esaote Europe B.V. had device recalls?
openFDA lists no recalls under a recalling firm name matching Esaote Europe B.V. Related entities may recall under other names.
Next steps
- See all 7 Esaote Europe B.V. clearances with predicates and recalls
- Run predicate analysis for product code IYN, Esaote Europe B.V.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.