510k
Database
Specialties
Anesthesiology
435
Cardiovascular
1321
Chemistry
327
Dental
1017
Ear, Nose, Throat
192
Gastroenterology & Urology
786
General & Plastic Surgery
1728
General Hospital
1125
Hematology
117
Immunology
83
Medical Genetics
7
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413
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739
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325
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200
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2380
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44
Physical Medicine
396
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1919
Toxicology
141
Categories
GEX
Powered Laser Surgical Instrument
283
LLZ
System, Image Processing,...
271
QIH
Automated Radiological Image...
247
GEI
Electrosurgical, Cutting &...
243
IYN
System, Imaging, Pulsed Doppler,...
235
HRS
Plate, Fixation, Bone
232
OLO
Orthopedic Stereotaxic Instrument
195
NHA
Abutment, Implant, Dental,...
182
LZA
Polymer Patient Examination Glove
176
MAX
Intervertebral Fusion Device...
165
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Csist
Medical Device Manufacturer
·
US , Denton , TX
Csist - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2001
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Csist
Radiology
✕
1
devices
1-1 of 1
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Cleared
Dec 20, 2001
CSIST DICOM GATEWAY/IMAGE MANAGER
K012327
·
LLZ
Radiology
·
150d
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1
Radiology
1