Medical Device Manufacturer · US , Waltham , MA

Dome Imaging Systems, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 1999

Recent clearances: DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL C5I, PACSCACHE

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Dome Imaging Systems, Inc. Radiology ✕

2 devices

1-2 of 2

Cleared Jun 16, 2004

DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL C5I

Radiology · 117d

Cleared Jan 14, 1999

Radiology · 78d

Data Source

Sourced from the FDA 510(k) public files . 176,583 total devices indexed.

Last updated: Sep 09, 2026