Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in ItalyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 8 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Esaote and its 4 subsidiaries with 132 510(k) clearances, 12 device recalls and 8 AI-enabled devices. The most recent is a 510(k) clearance dated Jul 31, 2026: I-Genius (100019400).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Esaote and its 4 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jul 31, 2026 | I-Genius (100019400)K261331 · LNH | 510(k) clearances |
| Apr 6, 2026 | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)K253288 · IYN | 510(k) clearances |
| Apr 6, 2026 | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)K253288 · Radiology | AI-enabled devices |
| Mar 27, 2026 | S-scan Open (100001800)K260746 · LNH | 510(k) clearances |
| Mar 27, 2026 | S-scan Open (100001800)K260746 · Radiology | AI-enabled devices |
| Mar 5, 2026 | Magnifico Open (100009900)K251901 · LNH | 510(k) clearances |
| Mar 5, 2026 | Magnifico Open (100009900)K251901 · Radiology | AI-enabled devices |
| Nov 25, 2025 | 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)K253310 · IYN | 510(k) clearances |
| Nov 25, 2025 | 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)K253310 · Radiology | AI-enabled devices |
| Nov 3, 2025 | 3mensio WorkstationK250330 · QIH | 510(k) clearances |
| Nov 3, 2025 | 3mensio WorkstationK250330 · Radiology | AI-enabled devices |
| Jun 18, 2025 | 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)K243253 · IYN | 510(k) clearances |
| Jun 18, 2025 | 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)K243253 · Radiology | AI-enabled devices |
| May 16, 2025 | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)K241671 · IYN | 510(k) clearances |
| May 16, 2025 | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)K241671 · Radiology | AI-enabled devices |
| Nov 29, 2023 | 6440 MyLabX90K230179 · Radiology | AI-enabled devices |
| Jun 26, 2014 | Esaote PA230E Transducer A portable and cart base ultrasound system for general and cardiovascular imagingClass II · Using the PA230E transducer with a user-defined setting with the output power to 100% (Max) in 2D-TEI mode focusing at m | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
