510k
Database
Specialties
Anesthesiology
204
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739
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187
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470
Ear, Nose, Throat
91
Gastroenterology & Urology
397
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777
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476
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77
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64
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1
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277
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303
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118
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79
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1478
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26
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153
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1095
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94
Categories
IYN
System, Imaging, Pulsed Doppler,...
167
HRS
Plate, Fixation, Bone
151
OLO
Orthopedic Stereotaxic Instrument
131
GEX
Powered Laser Surgical Instrument
127
LLZ
System, Image Processing,...
125
QIH
Automated Radiological Image...
112
GEI
Electrosurgical, Cutting &...
105
NHA
Abutment, Implant, Dental,...
105
MAX
Intervertebral Fusion Device...
96
NKB
Thoracolumbosacral Pedicle Screw...
93
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Radiology Information Systems, Inc.
Medical Device Manufacturer
·
US , Crofton , MD
Radiology Information Systems, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 1997
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Radiology Information Systems, Inc.
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Aug 16, 2019
PowerDR
K191504
·
JAA
Radiology
·
71d
Cleared
Nov 23, 2010
ACCULMAING
K102849
·
LLZ
Radiology
·
55d
Cleared
May 02, 1997
RIS SCANVIEW SYSTEM (RSVS)
K970641
·
LMD
Radiology
·
71d
Filters
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3
Radiology
3