510k
Database
Specialties
Anesthesiology
130
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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
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163
Obstetrics & Gynecology
60
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49
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1285
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18
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85
Radiology
866
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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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SimBioSys, Inc.
Medical Device Manufacturer
·
US , Chicago , IL
SimBioSys, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2023
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by SimBioSys, Inc.
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Jul 08, 2025
TumorSight Viz
K251766
·
QIH
Radiology
·
29d
Cleared
Oct 25, 2024
TumorSight Viz
K243189
·
QIH
Radiology
·
25d
Cleared
Dec 26, 2023
TumorSight Viz
K231130
·
QIH
Radiology
·
250d
Filters
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3
Radiology
3