510k
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2178
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352
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1732
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252
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229
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223
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221
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Plate, Fixation, Bone
216
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208
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Orthopedic Stereotaxic Instrument
180
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Abutment, Implant, Dental,...
169
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Thoracolumbosacral Pedicle Screw...
148
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Intervertebral Fusion Device...
146
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Suni Medical Imaging, Inc.
Medical Device Manufacturer
·
US , San Jose , CA
Suni Medical Imaging, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2006
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Suni Medical Imaging, Inc.
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
Nov 04, 2016
SuniIQ Digital Radiography System
K162585
·
MUH
Radiology
·
49d
Cleared
Jun 02, 2009
X-RAY, TOMOGRAPHY, COMPUTED, DENTAL
K083917
·
OAS
Radiology
·
154d
Cleared
Feb 07, 2007
SUNIRAY II DIGITAL RADIOGRAPHY SYSTEM
K070219
·
MUH
Radiology
·
15d
Cleared
Feb 03, 2006
SUNIPAN IMAGING SYSTEM & ACCESSORIES
K060149
·
MUH
Radiology
·
14d
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4
Radiology
4