# Siemens Medical Solutions USA, Inc., Ultrasound DI

- Location (FDA's records): Mountainview, CA
- FDA decisions: 11 (2007–2017): 11 510(k) clearances
- Product codes: IYN (8), IYO (2), JAK (1)
- Predicates its devices cite: 25 (5 its own); citations of its devices by later devices: 40 (5 its own)
- Recalls linked to its devices: 20 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Siemens Medical Solutions USA, Inc.: 19 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Siemens Medi Cal Solutions, Inc.: 1 (https://510kreport.com/company/siemens-medi-cal-solutions)

## Firms that cite its devices most
- Siemens Medical Solutions USA, Inc.: 15 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Siemens Medical Solutions USA, Inc. Ultrasound Gro: 5 (https://510kreport.com/company/siemens-medical-solutions-usa-ultrasound-gro)
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.: 4 (https://510kreport.com/company/shenzhen-mindray-bio-medical-electronics)
- Siemens Medi Cal Solutions, Inc.: 2 (https://510kreport.com/company/siemens-medi-cal-solutions)
- Diacardio, Ltd.: 2 (https://510kreport.com/company/diacardio)
- Tomtec Imaging Systems GmbH: 1 (https://510kreport.com/company/tomtec-imaging-systems)
- Qingdao Hisense Medical Equipment Co., Ltd.: 1 (https://510kreport.com/company/qingdao-hisense-medical-equipment)
- Paieon, Inc.: 1 (https://510kreport.com/company/paieon)

## Its most-cited devices
- K112596: Acuson S2000 Diagnostic Ultrasound System (2011), cited by 6
- K071036: Modification to Acuson X300 Ultrasound System (2007), cited by 6
- K081148: Siemens Acuson 2000 Ultrasound System with Abvs Transducer (2008), cited by 6
- K072365: Sequoia Plus Diagnostic Ultrasound System (2007), cited by 6
- K072090: Siemens Diagnostic Ultrasound Systems (2007), cited by 5
- K113179: Acuson SC2000 Diagnostic Ultrasound System (2011), cited by 4

## Recent decisions
- K163289: syngo. CT Single Source Dual Energy (twin beam) (Feb 9, 2017)
- K113179: Acuson SC2000 Diagnostic Ultrasound System (Dec 7, 2011)
- K112596: Acuson S2000 Diagnostic Ultrasound System (Sep 16, 2011)
- K081148: Siemens Acuson 2000 Ultrasound System with Abvs Transducer (Dec 22, 2008)
- K082142: Acuson S2000 Diagnostic Ultrasound System (Nov 13, 2008)
- K081121: Modification to Acuson X150 Ultrasound System (Jun 4, 2008)
- K080760: Acuson X300 Ultrasound System (Apr 25, 2008)
- K072365: Sequoia Plus Diagnostic Ultrasound System (Oct 17, 2007)

Source page: https://510kreport.com/company/siemens-medical-solutions-usa-ultrasound-di