510k
Database
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Anesthesiology
450
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1367
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334
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1058
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194
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808
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1780
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1214
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121
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84
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7
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420
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767
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336
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211
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2426
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44
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410
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1977
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143
Categories
GEX
Powered Laser Surgical Instrument
290
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System, Image Processing,...
281
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Electrosurgical, Cutting &...
253
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Automated Radiological Image...
251
IYN
System, Imaging, Pulsed Doppler,...
241
HRS
Plate, Fixation, Bone
236
LZA
Polymer Patient Examination Glove
206
OLO
Orthopedic Stereotaxic Instrument
198
NHA
Abutment, Implant, Dental,...
187
MAX
Intervertebral Fusion Device...
168
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Chicago X-Ray Systems, Inc.
Medical Device Manufacturer
·
US , Wheeling , IL
Chicago X-Ray Systems, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1994
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Chicago X-Ray Systems, Inc.
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
Oct 08, 1997
ROTOGRAPH PLUS
K972968
·
EHD
Radiology
·
58d
Cleared
Oct 27, 1995
EXPLOR-X (AZTEH) HF
K954565
·
EAP
Radiology
·
25d
Cleared
Apr 06, 1995
AZTECH 65 WITH CCD (COMPUTER CONTROLLED DENSITY) TIMER
K950667
·
EAP
Radiology
·
52d
Cleared
Mar 21, 1994
FLASH DENT
K931300
·
EHD
Radiology
·
371d
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4
Radiology
4