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) K261331 I-Genius (100019400)LNH2026-07-31 View
510(k) K253288 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)IYN2026-04-06 View
510(k) K260746 S-scan Open (100001800)LNH2026-03-27 View
510(k) K251901 Magnifico Open (100009900)LNH2026-03-05 View
510(k) K253310 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)IYN2025-11-25 View
510(k) K243253 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)IYN2025-06-18 View
510(k) K241671 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)IYN2025-05-16 View
510(k) K241133 Magnifico Open (100009900); Magnifico MSK ( 100009910)LNH2024-06-26 View
510(k) K230179 6440 MyLabX90IYN2023-11-29 View
510(k) K212419 Magnifico Open, Magnifico MSKLNH2022-02-04 View
510(k) K212021 6430 MyLabX75, 6430 MyLab XPro75IYN2021-09-16 View
510(k) K192157 6450 Ultrasound systemIYN2019-11-22 View
510(k) K191072 7410 Ultrasound System (MyLabSigma)IYN2019-06-10 View
510(k) K190989 6400 Ultrasound System (MyLabX6, MyLabX7)IYN2019-05-10 View
510(k) K183685 O-ScanLNH2019-01-22 View
510(k) K183191 6420 Ultrasound SystemIYN2018-12-04 View
510(k) K180592 G-scan BrioLNH2018-03-30 View
510(k) K173291 6440 Ultrasound SystemIYN2018-01-12 View
510(k) K163082 6200 Ultrasound System and 6250 Ultrasound SystemIYN2017-03-16 View
510(k) K161973 G-scan Brio, S-scanLNH2016-10-25 View

Page 1 of 2

↑