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510k Database
Manufacturers
US
Viztek, LLC
Medical Device Manufacturer
·
US , Naples , FL
Viztek, LLC - FDA 510(k) Cleared Devices
6 submissions
·
6 cleared
·
Since 2011
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Viztek, LLC
Radiology
✕
6
devices
1-6 of 6
Filters
Cleared
May 20, 2016
ViZion DR + Wireless
K160810
·
MQB
Radiology
·
57d
Cleared
Sep 10, 2015
ViZion DR + Wireless
K152279
·
MQB
Radiology
·
29d
Cleared
Dec 16, 2014
EXA
K142919
·
LLZ
Radiology
·
69d
Cleared
Apr 03, 2014
VIZION ULTRA
K133139
·
MQB
Radiology
·
168d
Cleared
Jan 11, 2013
VIZION + DR
K123644
·
MQB
Radiology
·
46d
Cleared
Oct 20, 2011
VIZION DR
K112661
·
MQB
Radiology
·
37d
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Radiology
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