510k
Database
Specialties
Anesthesiology
140
Cardiovascular
577
Chemistry
167
Dental
324
Ear, Nose, Throat
68
Gastroenterology & Urology
294
General & Plastic Surgery
533
General Hospital
380
Hematology
67
Immunology
58
Medical Genetics
0
Microbiology
234
Neurology
173
Obstetrics & Gynecology
67
Ophthalmic
52
Orthopedic
1300
Pathology
18
Physical Medicine
88
Radiology
885
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
152
HRS
Plate, Fixation, Bone
135
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
87
MBI
Fastener, Fixation,...
85
MAX
Intervertebral Fusion Device...
84
LNH
System, Nuclear Magnetic...
83
NKB
Thoracolumbosacral Pedicle Screw...
82
JAK
System, X-ray, Tomography, Computed
79
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About
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Imbio, LLC
Medical Device Manufacturer
·
US , Minneapolis , MN
Imbio, LLC - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2014
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Imbio, LLC
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Mar 09, 2021
Imbio RV/LV Software
K203256
·
QIH
Radiology
·
125d
Cleared
Mar 16, 2018
Imbio Segmentation Editing Tool software
K180129
·
LLZ
Radiology
·
58d
Cleared
Sep 17, 2014
Lung Density Analysis
K141069
·
JAK
Radiology
·
146d
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3
Radiology
3