Medical Device Manufacturer · IL , Kfar Saba

Spectrum Dynamics , Ltd. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2006

3

Total

3

Cleared

0

Denied

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

3 devices

1-3 of 3

Cleared Mar 21, 2016

D-SPECT Processing and Reviewing Workstation

Radiology · 62d

Cleared Oct 01, 2007

MODIFICATION TO D-SPECT CARDIAC SCANNER SYSTEM

Radiology · 27d

Cleared Oct 20, 2006

D-SPECT CARDIAC SCANNER SYSTEM

Radiology · 59d