510k
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1322
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4827
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3434
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2802
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474
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2478
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4194
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3883
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850
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800
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15
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1921
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1836
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893
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497
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8079
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176
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972
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5126
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1258
Categories
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System, Image Processing,...
757
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696
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System, Imaging, Pulsed Doppler,...
579
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Electrosurgical, Cutting &...
570
GEX
Powered Laser Surgical Instrument
523
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Prosthesis, Knee,...
522
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Polymer Patient Examination Glove
489
LNH
System, Nuclear Magnetic...
475
MAX
Intervertebral Fusion Device...
436
HWC
Screw, Fixation, Bone
403
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Manufacturers
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Manufacturers
US
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