510k
Database
Specialties
Anesthesiology
459
Cardiovascular
1392
Chemistry
334
Dental
1086
Ear, Nose, Throat
200
Gastroenterology & Urology
826
General & Plastic Surgery
1827
General Hospital
1292
Hematology
124
Immunology
85
Medical Genetics
7
Microbiology
420
Neurology
779
Obstetrics & Gynecology
348
Ophthalmic
220
Orthopedic
2444
Pathology
47
Physical Medicine
417
Radiology
2017
Toxicology
143
Categories
GEX
Powered Laser Surgical Instrument
298
LLZ
System, Image Processing,...
294
GEI
Electrosurgical, Cutting &...
256
QIH
Automated Radiological Image...
253
IYN
System, Imaging, Pulsed Doppler,...
243
HRS
Plate, Fixation, Bone
241
LZA
Polymer Patient Examination Glove
225
OLO
Orthopedic Stereotaxic Instrument
199
NHA
Abutment, Implant, Dental,...
190
MAX
Intervertebral Fusion Device...
169
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Eigen Video
Medical Device Manufacturer
·
US , Nevada City , CA
Eigen Video - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1985
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Eigen Video
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
Aug 24, 1994
DIGITAL MEDIA CONVERTER (D-MC)
K935026
·
IZI
Radiology
·
308d
Cleared
Jul 20, 1994
DDR WITH DPA AND 30/60 OPTIONS (DIGITAL VIEWSTATION)
K942264
·
JAA
Radiology
·
72d
Cleared
Apr 19, 1985
DIGITAL IMAGE PROCESSOR FP-2C
K850080
·
LLZ
Radiology
·
99d
Cleared
Mar 26, 1985
EIGEN FLORO-STOR FS-100
K844375
·
JAA
Radiology
·
133d
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4
Radiology
4