Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Esaote, S.p.A.

FDA 510(k) & PMA Approved Devices — 25 products

Total Devices25
Categories2
Latest FDA decision2026-07-31
TypeNumberDevice NameCodeDateActions
510(k) K162290 MyLabSix CrystaLineIYN2016-10-14 View
510(k) K161359 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemIYN2016-07-19 View
510(k) K161238 S-scanLNH2016-07-08 View
510(k) K153277 6200 Ultrasound System and 6250 Ultrasound SystemIYN2016-05-04 View
510(k) K153039 MRI Dynamic Analysis PlusLNH2016-01-08 View

Page 2 of 2

↑