510k
Database
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1353
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332
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1051
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194
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803
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1767
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1193
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120
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84
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7
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418
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760
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332
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208
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2415
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44
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405
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1958
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142
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Powered Laser Surgical Instrument
287
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System, Image Processing,...
279
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Electrosurgical, Cutting &...
250
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Automated Radiological Image...
249
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System, Imaging, Pulsed Doppler,...
238
HRS
Plate, Fixation, Bone
235
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Polymer Patient Examination Glove
199
OLO
Orthopedic Stereotaxic Instrument
198
NHA
Abutment, Implant, Dental,...
187
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Thoracolumbosacral Pedicle Screw...
167
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Mitra Imaging, Inc.
Medical Device Manufacturer
·
CA , Waterloo, Ontario
Mitra Imaging, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 1997
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Mitra Imaging, Inc.
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Nov 03, 1998
MITRA IMAGING INC. EXHIBIT
K982769
·
LLZ
Radiology
·
88d
Cleared
Jan 20, 1998
MILTRA IMAGING INC., IMAGE VAULT
K974102
·
LMD
Radiology
·
81d
Cleared
May 02, 1997
MITRA IMAGING, INC. FILM EXPRESS SCANNING SOFTWARE
K970652
·
LMD
Radiology
·
70d
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3
Radiology
3