510k
Database
Specialties
Anesthesiology
437
Cardiovascular
1336
Chemistry
329
Dental
1030
Ear, Nose, Throat
192
Gastroenterology & Urology
792
General & Plastic Surgery
1747
General Hospital
1149
Hematology
117
Immunology
84
Medical Genetics
7
Microbiology
413
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744
Obstetrics & Gynecology
329
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204
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2391
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44
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399
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1930
Toxicology
141
Categories
GEX
Powered Laser Surgical Instrument
285
LLZ
System, Image Processing,...
275
QIH
Automated Radiological Image...
247
GEI
Electrosurgical, Cutting &...
247
IYN
System, Imaging, Pulsed Doppler,...
235
HRS
Plate, Fixation, Bone
232
OLO
Orthopedic Stereotaxic Instrument
196
NHA
Abutment, Implant, Dental,...
184
LZA
Polymer Patient Examination Glove
184
MAX
Intervertebral Fusion Device...
165
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Image-Guided Neurologics, Inc.
Medical Device Manufacturer
·
US , Melbourne , FL
Image-Guided Neurologics, Inc. - FDA 510(k) Cleared Devices
22 submissions
·
22 cleared
·
Since 1999
22
Total
22
Cleared
0
Denied
FDA 510(k) Regulatory Record - Image-Guided Neurologics, Inc.
Radiology
✕
2
devices
1-2 of 2
Filters
Cleared
Jan 18, 2001
ACTIVE ARRAY CATHETER, MODEL CS-2000
K001097
·
MOS
Radiology
·
289d
Cleared
Jan 20, 2000
MRI EQUIPMENT COVER
K993682
·
LNH
Radiology
·
80d
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22
Neurology
20
Radiology
2