510k
Database
Specialties
Anesthesiology
207
Cardiovascular
741
Chemistry
187
Dental
472
Ear, Nose, Throat
92
Gastroenterology & Urology
398
General & Plastic Surgery
783
General Hospital
478
Hematology
77
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64
Medical Genetics
1
Microbiology
277
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309
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121
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81
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1482
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26
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155
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1101
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95
Categories
IYN
System, Imaging, Pulsed Doppler,...
168
HRS
Plate, Fixation, Bone
151
OLO
Orthopedic Stereotaxic Instrument
131
GEX
Powered Laser Surgical Instrument
128
LLZ
System, Image Processing,...
126
QIH
Automated Radiological Image...
113
NHA
Abutment, Implant, Dental,...
105
GEI
Electrosurgical, Cutting &...
105
MAX
Intervertebral Fusion Device...
97
MBI
Fastener, Fixation,...
93
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Perimeter Medical Imaging, Inc.
Medical Device Manufacturer
·
CA , Toronto
Perimeter Medical Imaging, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
1 cleared
·
Since 2016
3
Total
1
Cleared
0
Denied
FDA 510(k) cleared devices by Perimeter Medical Imaging, Inc.
General & Plastic Surgery
✕
3
devices
1-3 of 3
Filters
Cleared
Mar 26, 2019
OTIS Optical Coherence Tomography SYstem
K190404
·
NQQ
General & Plastic Surgery
·
35d
Cleared
Aug 25, 2017
OTIS Optical Coherence Tomography System
K171560
·
NQQ
General & Plastic Surgery
·
87d
Cleared
May 13, 2016
Perimeter Otis™ 1.0 Optical Coherence Tomography System
K160240
·
NQQ
General & Plastic Surgery
·
102d
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3
General & Plastic Surgery
3