# Biosound, Inc.

- Location (FDA's records): Indianapolis, IN
- FDA decisions: 39 (1983–1997): 39 510(k) clearances
- Product codes: ITX (13), DXK (5), IYO (4), GWQ (3), DPS (3), LNH (2), JOP (2), GWF (1), OLT (1), DPW (1), LMB (1), IYN (1)
- Predicates its devices cite: 20 (4 its own); citations of its devices by later devices: 16 (4 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
- Hitachi Medical Systems America, Inc.: 3 (https://510kreport.com/company/hitachi-medical-systems-america)
- Aloka Co., Ltd.: 1 (https://510kreport.com/company/aloka)
- Nicolet Instrument Corp.: 1 (https://510kreport.com/company/nicolet-instrument)
- Diasonics, Inc.: 1 (https://510kreport.com/company/diasonics)
- Mri Devices Corp.: 1 (https://510kreport.com/company/mri-devices)
- Medical Advances, Inc.: 1 (https://510kreport.com/company/medical-advances)
- Siemens Medical Solutions USA, Inc.: 1 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Philips Medical Systems, Inc.: 1 (https://510kreport.com/company/philips-medical-systems)

## Firms that cite its devices most
- Biosound Esaote, Inc.: 8 (https://510kreport.com/company/biosound-esaote)
- Dynamic Imaging, Inc.: 1 (https://510kreport.com/company/dynamic-imaging)
- Eb Neuro S.P.A.: 1 (https://510kreport.com/company/eb-neuro)
- Diagnostic Medical Systems: 1 (https://510kreport.com/company/diagnostic-medical-systems)
- Esaote, S.p.A.: 1 (https://510kreport.com/company/esaote)

## Its most-cited devices
- K963262: Artoscan M (1997), cited by 3
- K944485: 4000 AU Ultrasound Imaging System (1995), cited by 3
- K944287: 7050 Ultrasound Imaging System (1995), cited by 2
- K922488: Phasis Electromyograph (1993), cited by 2
- K923950: The Galileo Vega-24 Electroencephalograph (1993), cited by 1
- K931022: Artoscan (1993), cited by 1

## Recent decisions
- K971700: Biopsy Accessory for Ultrasound Transducer (Jul 9, 1997)
- K963936: Accesspoint, Med E-Mail, Dicom Reader (Mar 31, 1997)
- K963262: Artoscan M (Mar 28, 1997)
- K963662: Galileo Evoked Potentialre (Feb 26, 1997)
- K953716: Intracavity Transducers (Apr 17, 1996)
- K953530: Diagnostic Ultrasound Tranducers P10A, P12A, PT10A, PA11-a (Apr 8, 1996)
- K953759: Diagnostic Ultrasound Transducer (Mar 1, 1996)
- K953819: Diagnostic Ultrasound Tranducer (Mar 1, 1996)

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