510k
Database
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418
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1263
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311
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960
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181
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751
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1628
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1020
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114
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80
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6
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405
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704
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312
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189
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2292
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43
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379
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1841
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138
Categories
GEX
Powered Laser Surgical Instrument
272
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System, Image Processing,...
256
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Automated Radiological Image...
241
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Electrosurgical, Cutting &...
227
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Plate, Fixation, Bone
226
IYN
System, Imaging, Pulsed Doppler,...
226
OLO
Orthopedic Stereotaxic Instrument
188
NHA
Abutment, Implant, Dental,...
174
NKB
Thoracolumbosacral Pedicle Screw...
155
LZA
Polymer Patient Examination Glove
153
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Scimage, Inc.
Medical Device Manufacturer
·
US , Los Altos , CA
Scimage, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 1996
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Scimage, Inc.
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Jan 09, 2008
SCIMAGE PICOMENTERPRISE
K073169
·
LLZ
Radiology
·
61d
Cleared
Jan 19, 2001
NETRA WORKSTATION AND NETRAMD SOFTWARE
K003484
·
LLZ
Radiology
·
71d
Cleared
May 29, 1996
NETRA WORKSTATION SYSTEM & NETRA MD SOFTWARE
K960911
·
LMD
Radiology
·
84d
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3
Radiology
3