510k
Database
Specialties
Anesthesiology
144
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584
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167
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328
Ear, Nose, Throat
68
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297
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543
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387
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67
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58
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0
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236
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175
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70
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53
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1308
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19
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91
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891
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88
Categories
IYN
System, Imaging, Pulsed Doppler,...
152
HRS
Plate, Fixation, Bone
138
OLO
Orthopedic Stereotaxic Instrument
118
LLZ
System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
87
MBI
Fastener, Fixation,...
85
MAX
Intervertebral Fusion Device...
84
LNH
System, Nuclear Magnetic...
84
NKB
Thoracolumbosacral Pedicle Screw...
83
JAK
System, X-ray, Tomography, Computed
79
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Caption Health
Medical Device Manufacturer
·
US , Brisbane , CA
Caption Health - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2020
4
Total
4
Cleared
0
Denied
FDA 510(k) cleared devices by Caption Health
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
Jan 19, 2022
Caption Interpretation Automated Ejection Fraction Software
K210747
·
QIH
Radiology
·
313d
Cleared
Sep 18, 2020
Caption Guidance
K201992
·
QJU
Radiology
·
63d
Cleared
Jul 22, 2020
Caption Interpretation Automated Ejection Fraction Software
K200621
·
QIH
Radiology
·
135d
Cleared
Apr 16, 2020
Caption Guidance
K200755
·
QJU
Radiology
·
24d
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4
Radiology
4