510k
Database
Specialties
Anesthesiology
435
Cardiovascular
1325
Chemistry
327
Dental
1018
Ear, Nose, Throat
192
Gastroenterology & Urology
787
General & Plastic Surgery
1729
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1127
Hematology
117
Immunology
83
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7
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413
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740
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326
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201
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2381
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44
Physical Medicine
396
Radiology
1922
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141
Categories
GEX
Powered Laser Surgical Instrument
284
LLZ
System, Image Processing,...
272
QIH
Automated Radiological Image...
247
GEI
Electrosurgical, Cutting &...
243
IYN
System, Imaging, Pulsed Doppler,...
235
HRS
Plate, Fixation, Bone
232
OLO
Orthopedic Stereotaxic Instrument
195
NHA
Abutment, Implant, Dental,...
182
LZA
Polymer Patient Examination Glove
176
MAX
Intervertebral Fusion Device...
165
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Insightful Corporation
Medical Device Manufacturer
·
US , Seattle , WA
Insightful Corporation - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2001
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Insightful Corporation
Radiology
✕
1
devices
1-1 of 1
Filters
Cleared
Nov 08, 2001
IQUANTIFY, VERSION 1.0
K011196
·
LLZ
Radiology
·
203d
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Radiology
1