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Manufacturers
US
Candelis, Inc.
Medical Device Manufacturer
·
US , Denton , TX
Candelis, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2008
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Candelis, Inc.
Radiology
✕
3
devices
1-3 of 3
Filters
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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3
Radiology
3