# U-System, Inc.

- Location (FDA's records): San Jose, CA
- FDA decisions: 1 (2008–2008): 1 510(k) clearance
- Product codes: IYO (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- U-Systems, Inc.: 1 (https://510kreport.com/company/u-systems)
- Siemens Medical Solutions USA, Inc.: 1 (https://510kreport.com/company/siemens-medical-solutions-usa)

## Firms that cite its devices most
- Siemens AG Medical Solutions: 1 (https://510kreport.com/company/siemens-ag-medical-solutions)

## Its most-cited devices
- K080930: Modification to Automated Breast Ultrasound System, Model Abus (2008), cited by 1

## Recent decisions
- K080930: Modification to Automated Breast Ultrasound System, Model Abus (Aug 7, 2008)

Source page: https://510kreport.com/company/u-system