Medical Device Manufacturer · US , Ormond Beach , FL

Owandy - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2006

Recent clearances: OPTEO, VIDEOGRAPH HD, I-MAX TOUCH 3D, VISTEO

View 6 510(k) Devices ↓

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Owandy Radiology ✕

6 devices

1-6 of 6

Cleared Apr 28, 2014

OPTEO, VIDEOGRAPH HD

Radiology · 186d

Cleared Jun 14, 2013

Radiology · 113d

Cleared Oct 18, 2010

Radiology · 382d

Cleared Jun 02, 2009

Radiology · 231d

Cleared Apr 05, 2007

Radiology · 43d

Cleared Nov 14, 2006

IMAX CEPH DIGITAL X-RAY SENSOR

Radiology · 89d