510k
Database
Specialties
Anesthesiology
422
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1276
Chemistry
311
Dental
966
Ear, Nose, Throat
182
Gastroenterology & Urology
752
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1637
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1037
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114
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80
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6
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405
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706
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315
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191
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2312
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43
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381
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1853
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138
Categories
GEX
Powered Laser Surgical Instrument
272
LLZ
System, Image Processing,...
258
QIH
Automated Radiological Image...
242
GEI
Electrosurgical, Cutting &...
227
HRS
Plate, Fixation, Bone
227
IYN
System, Imaging, Pulsed Doppler,...
227
OLO
Orthopedic Stereotaxic Instrument
188
NHA
Abutment, Implant, Dental,...
175
LZA
Polymer Patient Examination Glove
160
NKB
Thoracolumbosacral Pedicle Screw...
157
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Intelerad Medical Systems, Inc.
Medical Device Manufacturer
·
US , Denton , TX
Intelerad Medical Systems, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2003
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Intelerad Medical Systems, Inc.
Radiology
✕
2
devices
1-2 of 2
Filters
Cleared
Jan 24, 2007
INTELEPACS
K070080
·
LLZ
Radiology
·
15d
Cleared
Oct 16, 2003
INTELEPACS
K032533
·
LLZ
Radiology
·
62d
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Radiology
2