# Biosound Esaote, Inc.

- Location (FDA's records): Indianapolis, IN
- FDA decisions: 20 (1997–2003): 20 510(k) clearances
- Product codes: IYN (7), LNH (4), IYO (3), LOS (1), DPS (1), LHN (1), ITX (1), MOS (1), GWQ (1)
- Predicates its devices cite: 22 (10 its own); citations of its devices by later devices: 48 (10 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Biosound, Inc.: 8 (https://510kreport.com/company/biosound)
- Esaote Biomedica Spa: 1 (https://510kreport.com/company/esaote-biomedica)
- Hitachi Medical Systems America, Inc.: 1 (https://510kreport.com/company/hitachi-medical-systems-america)
- Elscint Mr, Inc.: 1 (https://510kreport.com/company/elscint-mr)
- Hitachi Medical Corp. of America: 1 (https://510kreport.com/company/hitachi-medical-of-america)

## Firms that cite its devices most
- Esaote, S.p.A.: 26 (https://510kreport.com/company/esaote)
- Ardent Sound, Inc.: 6 (https://510kreport.com/company/ardent-sound)
- Pie Medical: 3 (https://510kreport.com/company/pie-medical)
- Dynamic Imaging, Inc.: 2 (https://510kreport.com/company/dynamic-imaging)
- Esaote Europe B.V.: 1 (https://510kreport.com/company/esaote-europe)

## Its most-cited devices
- K014168: AU6 (Technos/Technos MP) Ultrasound Imaging System (Addition of 3D Imaging Mode and Musculoskeletal Indication) (2002), cited by 7
- K982444: 7250 Ultrasound Imaging System (1998), cited by 5
- K980468: AU5 Ultrasound Imaging System (1998), cited by 5
- K000681: AU5, AU6 (2000), cited by 4
- K990360: AU6 (1999), cited by 4
- K001894: Modification to E-Scan (2000), cited by 4

## Recent decisions
- K023255: Technos MP, Model AU6 (Feb 11, 2003)
- K014168: AU6 (Technos/Technos MP) Ultrasound Imaging System (Addition of 3D Imaging Mode and Musculoskeletal Indication) (Apr 25, 2002)
- K020164: E-Scan XQ (Feb 12, 2002)
- K012728: E-Scan Mri System (Aug 29, 2001)
- K010405: 7230 Ultrasound Imaging System with Tei (Mar 13, 2001)
- K010057: Modification to Artoscan M (Feb 2, 2001)
- K001894: Modification to E-Scan (Jul 6, 2000)
- K000931: AU5 Ultrasound Imaging System (Jun 8, 2000)

Source page: https://510kreport.com/company/biosound-esaote