510k
Database
Specialties
Anesthesiology
130
Cardiovascular
565
Chemistry
162
Dental
309
Ear, Nose, Throat
68
Gastroenterology & Urology
286
General & Plastic Surgery
511
General Hospital
369
Hematology
67
Immunology
56
Medical Genetics
0
Microbiology
232
Neurology
163
Obstetrics & Gynecology
60
Ophthalmic
49
Orthopedic
1285
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18
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85
Radiology
866
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
133
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
99
MBI
Fastener, Fixation,...
84
NHA
Abutment, Implant, Dental,...
83
LNH
System, Nuclear Magnetic...
83
MAX
Intervertebral Fusion Device...
82
NKB
Thoracolumbosacral Pedicle Screw...
80
JAK
System, X-ray, Tomography, Computed
79
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Imbio, Inc.
Medical Device Manufacturer
·
US , Minneapolis , MN
Imbio, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2023
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Imbio, Inc.
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Dec 19, 2024
IQ-UIP
K242467
·
QWO
Radiology
·
121d
Cleared
Aug 30, 2024
Imbio PHA (4.0.0)
K241847
·
QIH
Radiology
·
65d
Cleared
Jun 13, 2023
CAC Software
K230112
·
JAK
Radiology
·
147d
Filters
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3
Radiology
3