510k
Database
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406
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1226
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305
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925
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176
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720
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1570
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953
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112
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79
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4
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399
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685
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293
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183
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2215
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42
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366
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1798
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138
Categories
GEX
Powered Laser Surgical Instrument
258
LLZ
System, Image Processing,...
248
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Automated Radiological Image...
236
IYN
System, Imaging, Pulsed Doppler,...
222
GEI
Electrosurgical, Cutting &...
219
HRS
Plate, Fixation, Bone
217
OLO
Orthopedic Stereotaxic Instrument
183
NHA
Abutment, Implant, Dental,...
169
NKB
Thoracolumbosacral Pedicle Screw...
151
MAX
Intervertebral Fusion Device...
146
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Ge Healthcare Integrated IT Solutions
Medical Device Manufacturer
·
US , Barrington , IL
Ge Healthcare Integrated IT Solutions - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2006
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ge Healthcare Integrated IT Solutions
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Jun 05, 2012
CENTRICITY PACS-IW
K121387
·
LLZ
Radiology
·
28d
Cleared
Nov 30, 2011
CENTRICITY CARDIO IMAGING
K112570
·
LLZ
Radiology
·
85d
Cleared
Dec 26, 2006
CENTRICITY RADIOLOGY RA600, CARDIOLOGY CA1000 AND DIGITAL HARDCOPY
K063628
·
LLZ
Radiology
·
20d
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4
Radiology
3
Obstetrics & Gynecology
1