Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of EsaoteLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Biosound Esaote with 20 510(k) clearances and 1 device recall. The most recent is a device recall dated Jun 26, 2014: Esaote PA230E Transducer A portable and cart base ultrasound system for general and car….
| 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 |
| Feb 11, 2003 | TECHNOS MP, MODEL AU6K023255 · IYN | 510(k) clearances |
| Apr 25, 2002 | AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION OF 3D IMAGING MODE AND MUSCULOSKELETAL INDICATION)K014168 · IYN | 510(k) clearances |
| Feb 12, 2002 | E-SCAN XQK020164 · LNH | 510(k) clearances |
| Aug 29, 2001 | E-SCAN MRI SYSTEMK012728 · MOS | 510(k) clearances |
| Mar 13, 2001 | 7230 ULTRASOUND IMAGING SYSTEM WITH TEIK010405 · IYN | 510(k) clearances |
| Feb 2, 2001 | MODIFICATION TO ARTOSCAN MK010057 · LNH | 510(k) clearances |
| Jul 6, 2000 | MODIFICATION TO E-SCANK001894 · LNH | 510(k) clearances |
| Jun 8, 2000 | AU5 ULTRASOUND IMAGING SYSTEMK000931 · IYN | 510(k) clearances |
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
