510k
Database
Specialties
Anesthesiology
540
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1660
Chemistry
362
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1329
Ear, Nose, Throat
244
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957
General & Plastic Surgery
2182
General Hospital
2039
Hematology
126
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97
Medical Genetics
8
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464
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962
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433
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274
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2862
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52
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515
Radiology
2418
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
382
FXX
Mask, Surgical
358
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Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
302
IYN
System, Imaging, Pulsed Doppler,...
288
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
219
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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) Regulatory Record - 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