Medical Device Manufacturer · US , Denton , TX

Candelis, Inc. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2008

Recent clearances: ImageGrid StreamVue, ASTRA, IMAGEGRID RADIOLOGY VIEWER SYSTEM

View 4 510(k) Devices ↓
4
Total
4
Cleared
0
Denied

FDA 510(k) Regulatory Record - Candelis, Inc. Radiology ✕

4 devices
1-4 of 4
Cleared Jul 23, 2026
ImageGrid StreamVue
K262143 · LLZ
Radiology · 28d
Cleared Sep 15, 2011
ASTRA
K111694 · LLZ
Radiology · 91d
Cleared Oct 08, 2009
IMAGEGRID RADIOLOGY VIEWER SYSTEM
K092949 · LLZ
Radiology · 14d
Cleared Feb 22, 2008
IMAGEGRID
K080333 · LLZ
Radiology · 15d
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