# U-Systems, Inc.

- Location (FDA's records): Los Altos,, CA
- FDA decisions: 6 (2001–2005): 6 510(k) clearances
- Product codes: IYN (4), IYO (2)
- Predicates its devices cite: 4 (2 its own); citations of its devices by later devices: 8 (2 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
- Siemens Medical Solutions USA, Inc.: 1 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Context Vision AB: 1 (https://510kreport.com/company/context-vision)

## Firms that cite its devices most
- Ivu Imaging Corporation: 2 (https://510kreport.com/company/ivu-imaging)
- Orison Corporation: 1 (https://510kreport.com/company/orison)
- U-System, Inc.: 1 (https://510kreport.com/company/u-system)
- Metritrack, Inc.: 1 (https://510kreport.com/company/metritrack)
- Sonocine, Inc.: 1 (https://510kreport.com/company/sonocine)

## Its most-cited devices
- K052355: Automated Breast Ultrasound System, Model Abus (2005), cited by 5
- K032640: Full Field Breast Imaging (Ffbu) Diagnostic Ultrasound System (2003), cited by 2
- K022517: Usi-2000 Ultrasound System with Automated Scanning Accessory (2002), cited by 1

## Recent decisions
- K052355: Automated Breast Ultrasound System, Model Abus (Sep 14, 2005)
- K032640: Full Field Breast Imaging (Ffbu) Diagnostic Ultrasound System (Sep 11, 2003)
- K022517: Usi-2000 Ultrasound System with Automated Scanning Accessory (Dec 24, 2002)
- K013902: U-Systems Diagnostic Ultrasound System Usi-2000 (Jun 5, 2002)
- K013848: U-Systems Diagnostic Ultrasound System U-2000 (Apr 8, 2002)
- K003479: U-Systems Ultrasound System Usi-2000 (Jan 18, 2001)

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