510k
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1236
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309
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936
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179
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1588
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113
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80
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400
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692
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298
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183
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2242
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43
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371
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1811
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138
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Powered Laser Surgical Instrument
261
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System, Image Processing,...
255
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Automated Radiological Image...
236
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System, Imaging, Pulsed Doppler,...
224
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Electrosurgical, Cutting &...
221
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Plate, Fixation, Bone
219
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Orthopedic Stereotaxic Instrument
184
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Abutment, Implant, Dental,...
169
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Thoracolumbosacral Pedicle Screw...
151
MAX
Intervertebral Fusion Device...
149
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Viztek, Inc.
Medical Device Manufacturer
·
US , Jacksonville , FL
Viztek, Inc. - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2001
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Viztek, Inc.
Radiology
✕
5
devices
1-5 of 5
Filters
Cleared
Jan 24, 2011
VIZION DR
K102123
·
KPR
Radiology
·
179d
Cleared
Nov 12, 2009
VIZTEK WL
K091752
·
KPR
Radiology
·
149d
Cleared
Nov 21, 2008
VIZTEK DR, MODELS: DR1000, DR3000, DR4000
K082604
·
KPR
Radiology
·
74d
Cleared
Dec 12, 2006
OPAL-RAD
K063337
·
LLZ
Radiology
·
36d
Cleared
Feb 15, 2001
ONYX-RAD TELEMEDICINE PACS
K003607
·
LLZ
Radiology
·
85d
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5
Radiology
5