510k
Database
Specialties
Anesthesiology
444
Cardiovascular
1348
Chemistry
331
Dental
1048
Ear, Nose, Throat
193
Gastroenterology & Urology
803
General & Plastic Surgery
1767
General Hospital
1188
Hematology
120
Immunology
84
Medical Genetics
7
Microbiology
418
Neurology
759
Obstetrics & Gynecology
332
Ophthalmic
208
Orthopedic
2413
Pathology
44
Physical Medicine
405
Radiology
1953
Toxicology
142
Categories
GEX
Powered Laser Surgical Instrument
287
LLZ
System, Image Processing,...
278
GEI
Electrosurgical, Cutting &...
250
QIH
Automated Radiological Image...
248
IYN
System, Imaging, Pulsed Doppler,...
238
HRS
Plate, Fixation, Bone
235
LZA
Polymer Patient Examination Glove
199
OLO
Orthopedic Stereotaxic Instrument
198
NHA
Abutment, Implant, Dental,...
187
MAX
Intervertebral Fusion Device...
167
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Sitco, Inc.
Medical Device Manufacturer
·
US , Mundelein , IL
Sitco, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1995
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sitco, Inc.
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
Mar 12, 1999
BIOPSY-DIGIT
K990192
·
IZH
Radiology
·
50d
Cleared
Jul 14, 1998
BIOPSY M
K982049
·
IZH
Radiology
·
33d
Cleared
Nov 21, 1997
GIOTTO HT
K973856
·
IZH
Radiology
·
43d
Cleared
Oct 24, 1995
NUQUEST NUCLEAR MEDICINE COMPUTER
K953255
·
KPS
Radiology
·
104d
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4
Radiology
4