510k
Database
Specialties
Anesthesiology
379
Cardiovascular
1185
Chemistry
288
Dental
878
Ear, Nose, Throat
163
Gastroenterology & Urology
691
General & Plastic Surgery
1486
General Hospital
876
Hematology
108
Immunology
77
Medical Genetics
1
Microbiology
387
Neurology
646
Obstetrics & Gynecology
273
Ophthalmic
172
Orthopedic
2175
Pathology
41
Physical Medicine
350
Radiology
1724
Toxicology
135
Categories
GEX
Powered Laser Surgical Instrument
250
QIH
Automated Radiological Image...
228
LLZ
System, Image Processing,...
222
IYN
System, Imaging, Pulsed Doppler,...
221
HRS
Plate, Fixation, Bone
216
GEI
Electrosurgical, Cutting &...
208
OLO
Orthopedic Stereotaxic Instrument
180
NHA
Abutment, Implant, Dental,...
169
NKB
Thoracolumbosacral Pedicle Screw...
147
MAX
Intervertebral Fusion Device...
146
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Hitachi Medical Systems America, Inc.
Medical Device Manufacturer
·
US , Twinsburg , OH
Hitachi Medical Systems America, Inc. - FDA 510(k) Cleared Devices
100 submissions
·
100 cleared
·
Since 1991
100
Total
100
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hitachi Medical Systems America, Inc.
Anesthesiology
✕
1
devices
1-1 of 1
Filters
Cleared
Aug 09, 2001
ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM
K011320
·
DQA
Anesthesiology
·
100d
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100
Radiology
99
Anesthesiology
1