Medical Device Manufacturer · US , Hatfield , PA

Imaging Sciences International - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2014

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Imaging Sciences International Radiology ✕

2 devices

1-2 of 2

Cleared Nov 10, 2016

i-CAT FLX V series / KaVo 3D eXam+ V series

Radiology · 106d

Cleared May 14, 2014

CONE BEAM 3D AND 2D PANORAMIC DENTAL IMAGING SYSTEM

Radiology · 170d