# Ultraspect, Ltd.

- Location (FDA's records): Haifa, IL
- FDA decisions: 6 (2004–2011): 6 510(k) clearances
- Product codes: KPS (6)
- Predicates its devices cite: 13 (9 its own); citations of its devices by later devices: 10 (9 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
- GE Medical Systems: 2 (https://510kreport.com/company/ge-medical-systems)
- Segami Corporation: 1 (https://510kreport.com/company/segami)
- U.C.G. Technologies, Ltd.: 1 (https://510kreport.com/company/ucg-technologies)

## Firms that cite its devices most
- Spectrum Dynamics (Israel), Ltd.: 1 (https://510kreport.com/company/spectrum-dynamics-israel)

## Its most-cited devices
- K080784: WBR Xpress.Cardiac, WBR Xpress.Bone; WBR Xact.Cardiac, WBR Xact.Bone (2008), cited by 4
- K050815: Xact.Cardiac & Xpress.Cardiac (2005), cited by 2
- K040370: WBR-FHR, WBR-FWB (2004), cited by 2
- K091073: WBR Xpress.Cardiac and XPRESS3.Cardiac Including Attenuation and Scattering Corrections (2009), cited by 1
- K081201: WBR XPRESS3.Cardiac (2008), cited by 1

## Recent decisions
- K103710: WBR Xpress Pet (Jan 19, 2011)
- K091073: WBR Xpress.Cardiac and XPRESS3.Cardiac Including Attenuation and Scattering Corrections (May 14, 2009)
- K081201: WBR XPRESS3.Cardiac (May 28, 2008)
- K080784: WBR Xpress.Cardiac, WBR Xpress.Bone; WBR Xact.Cardiac, WBR Xact.Bone (Apr 2, 2008)
- K050815: Xact.Cardiac & Xpress.Cardiac (Apr 26, 2005)
- K040370: WBR-FHR, WBR-FWB (Mar 11, 2004)

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