510k
Database
Specialties
Anesthesiology
379
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1185
Chemistry
288
Dental
879
Ear, Nose, Throat
163
Gastroenterology & Urology
693
General & Plastic Surgery
1491
General Hospital
879
Hematology
108
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77
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1
Microbiology
387
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647
Obstetrics & Gynecology
274
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172
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2175
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41
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352
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1728
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136
Categories
GEX
Powered Laser Surgical Instrument
251
QIH
Automated Radiological Image...
228
LLZ
System, Image Processing,...
223
IYN
System, Imaging, Pulsed Doppler,...
221
HRS
Plate, Fixation, Bone
216
GEI
Electrosurgical, Cutting &...
208
OLO
Orthopedic Stereotaxic Instrument
180
NHA
Abutment, Implant, Dental,...
169
NKB
Thoracolumbosacral Pedicle Screw...
147
MAX
Intervertebral Fusion Device...
146
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Canon Inc. -Medical Equipment Group
Medical Device Manufacturer
·
JP , Tachikawa-Shi, Tokyo
Canon Inc. -Medical Equipment Group - FDA 510(k) Cleared Devices
11 submissions
·
11 cleared
·
Since 2010
11
Total
11
Cleared
0
Denied
FDA 510(k) Regulatory Record - Canon Inc. -Medical Equipment Group
Ophthalmic
✕
4
devices
1-4 of 4
Filters
Cleared
Feb 23, 2018
Ophthalmic Software Platform RX
K173689
·
NFJ
Ophthalmic
·
84d
Cleared
Mar 19, 2013
DIGITAL RETINAL CAMERA
K123208
·
HKI
Ophthalmic
·
158d
Cleared
Sep 20, 2011
FULL AUTO TONOMETER MODEL TX-20
K111710
·
HKX
Ophthalmic
·
92d
Cleared
Oct 29, 2010
DIGITAL RETINAL CAMERA
K102013
·
HKI
Ophthalmic
·
105d
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11
Radiology
7
Ophthalmic
4