Medical Device Manufacturer · IL , Haifa

Ultraspect , Ltd. - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2004

Recent clearances: WBR XPRESS PET, WBR XPRESS.CARDIAC AND XPRESS3.CARDIAC INCLUDING ATTENUATION AND SCATTERING CORRECTIONS, WBR XPRESS3.CARDIAC

View 6 510(k) Devices ↓

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Ultraspect , Ltd. Radiology ✕

6 devices

1-6 of 6

Cleared Jan 19, 2011

Radiology · 30d

Cleared May 14, 2009

WBR XPRESS.CARDIAC AND XPRESS3.CARDIAC INCLUDING ATTENUATION AND SCATTERING...

Radiology · 30d

Cleared May 28, 2008

WBR XPRESS3.CARDIAC

Radiology · 30d

Cleared Apr 02, 2008

WBR XPRESS.CARDIAC, WBR XPRESS.BONE

Radiology · 13d

Cleared Apr 26, 2005

XACT.CARDIAC & XPRESS.CARDIAC

Radiology · 26d

Cleared Mar 11, 2004

WBR-FHR, WBR-FWB

Radiology · 27d