510k
Database
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Anesthesiology
417
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1258
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311
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957
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181
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749
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1618
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1006
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114
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80
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6
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405
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702
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308
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189
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2276
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43
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379
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1838
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138
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GEX
Powered Laser Surgical Instrument
272
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System, Image Processing,...
256
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Automated Radiological Image...
240
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System, Imaging, Pulsed Doppler,...
226
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Electrosurgical, Cutting &...
225
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Plate, Fixation, Bone
223
OLO
Orthopedic Stereotaxic Instrument
187
NHA
Abutment, Implant, Dental,...
172
NKB
Thoracolumbosacral Pedicle Screw...
155
LZA
Polymer Patient Examination Glove
153
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Amicas, Inc.
Medical Device Manufacturer
·
US , Boston , MA
Amicas, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2002
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Amicas, Inc.
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
Sep 05, 2008
AMICAS PACS, VERSION 6.0
K082144
·
LLZ
Radiology
·
37d
Cleared
Mar 12, 2008
AMICAS VISION SERIES PACS, MODEL 5.5
K073526
·
LLZ
Radiology
·
86d
Cleared
Oct 27, 2006
AMICAS VISION SERIES PACS, MODEL 4.3
K062477
·
LLZ
Radiology
·
64d
Cleared
Nov 22, 2002
AMICAS LIGHT BEAM WORKSTATION, MODEL 1.0
K022970
·
LLZ
Radiology
·
77d
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4
Radiology
4