# Medison America, Inc.

- Location (FDA's records): Pleasanton, CA
- FDA decisions: 21 (1993–2003): 21 510(k) clearances
- Product codes: IYO (10), IYN (9), ITX (2)
- Predicates its devices cite: 27 (22 its own); citations of its devices by later devices: 52 (22 its own)
- Recalls linked to its devices: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Advanced Technology Laboratories, Inc.: 3 (https://510kreport.com/company/advanced-technology-laboratories)
- Medison Co., Ltd.: 1 (https://510kreport.com/company/medison)
- Toshiba America Medical Systems, In.C: 1 (https://510kreport.com/company/toshiba-america-medical-systems-in-c)

## Firms that cite its devices most
- Medison Co., Ltd.: 9 (https://510kreport.com/company/medison)
- General Electric Co.: 4 (https://510kreport.com/company/general-electric)
- Philips Ultrasound, Inc.: 3 (https://510kreport.com/company/philips-ultrasound)
- Siemens Medical Solutions USA, Inc.: 2 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Shantou Institute of Ultrasonic Instuments: 2 (https://510kreport.com/company/shantou-institute-of-ultrasonic-instuments)
- Sonoscape Company Limited: 2 (https://510kreport.com/company/sonoscape)
- Advanced Technology Laboratories, Inc.: 1 (https://510kreport.com/company/advanced-technology-laboratories)
- Telemed: 1 (https://510kreport.com/company/telemed)

## Its most-cited devices
- K003525: Voluson 730 Diagnostic Ultrasound System (2000), cited by 10
- K974269: SA8800 Diagnostic Ultrasound System and Transducers, (1998), cited by 8
- K013627: Sonoace SA-8000 Diagnostic Ultrasound System (2001), cited by 6
- K002185: Sonoace SA 9900 Diagnostic Ultrasound System (2000), cited by 5
- K974813: Combison 530D with Power Doppler Mode (1998), cited by 3
- K000030: Sonoace 600 Diagnostic Ultrasound System (2000), cited by 3

## Recent decisions
- K032329: SA 9900 Plus Diagnostic Ultrasound System (Aug 6, 2003)
- K031552: Mycolor 202 Diagnostic Ultrasound System and Transducers (May 30, 2003)
- K013627: Sonoace SA-8000 Diagnostic Ultrasound System (Nov 16, 2001)
- K012887: SA6000II Diagnostic Ultrasound System (Sep 12, 2001)
- K012867: Sonoace 9900 Diagnostic Ultrasound System (Sep 12, 2001)
- K003525: Voluson 730 Diagnostic Ultrasound System (Nov 22, 2000)
- K003121: Mysono 201 Diagnostic Ultrasound and Transducers (Oct 20, 2000)
- K002185: Sonoace SA 9900 Diagnostic Ultrasound System (Aug 1, 2000)

Source page: https://510kreport.com/company/medison-america