510k
Database
Specialties
Anesthesiology
456
Cardiovascular
1383
Chemistry
334
Dental
1080
Ear, Nose, Throat
198
Gastroenterology & Urology
821
General & Plastic Surgery
1817
General Hospital
1259
Hematology
123
Immunology
85
Medical Genetics
7
Microbiology
420
Neurology
775
Obstetrics & Gynecology
341
Ophthalmic
217
Orthopedic
2435
Pathology
46
Physical Medicine
416
Radiology
2003
Toxicology
143
Categories
GEX
Powered Laser Surgical Instrument
297
LLZ
System, Image Processing,...
290
GEI
Electrosurgical, Cutting &...
256
QIH
Automated Radiological Image...
253
IYN
System, Imaging, Pulsed Doppler,...
242
HRS
Plate, Fixation, Bone
237
LZA
Polymer Patient Examination Glove
215
OLO
Orthopedic Stereotaxic Instrument
199
NHA
Abutment, Implant, Dental,...
189
MAX
Intervertebral Fusion Device...
169
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Mci Optonix, Inc.
Medical Device Manufacturer
·
US , Cedar Knolls , NJ
Mci Optonix, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1990
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Mci Optonix, Inc.
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
Aug 02, 1995
MCI OPTONIX ECONOMY CASSETTE
K953444
·
IXA
Radiology
·
16d
Cleared
Nov 22, 1994
MCI OPTONIX CASSETTE OKAMOTO CASSETE
K945039
·
IXA
Radiology
·
39d
Cleared
Mar 30, 1994
RAREX GREEN FAST
K941023
·
EAM
Radiology
·
27d
Cleared
Jul 27, 1990
RAREX & OPTEX X-RAY SCREENS
K902039
·
EAM
Radiology
·
84d
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4
Radiology
4