510k
Database
Specialties
Anesthesiology
440
Cardiovascular
1343
Chemistry
331
Dental
1036
Ear, Nose, Throat
192
Gastroenterology & Urology
796
General & Plastic Surgery
1757
General Hospital
1168
Hematology
118
Immunology
84
Medical Genetics
7
Microbiology
414
Neurology
751
Obstetrics & Gynecology
331
Ophthalmic
205
Orthopedic
2401
Pathology
44
Physical Medicine
402
Radiology
1942
Toxicology
141
Categories
GEX
Powered Laser Surgical Instrument
287
LLZ
System, Image Processing,...
277
GEI
Electrosurgical, Cutting &...
249
QIH
Automated Radiological Image...
247
IYN
System, Imaging, Pulsed Doppler,...
237
HRS
Plate, Fixation, Bone
234
OLO
Orthopedic Stereotaxic Instrument
197
LZA
Polymer Patient Examination Glove
190
NHA
Abutment, Implant, Dental,...
184
MAX
Intervertebral Fusion Device...
165
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Hitachi Medical Corp. of America
Medical Device Manufacturer
·
US , Tarrytown , NY
Hitachi Medical Corp. of America - FDA 510(k) Cleared Devices
32 submissions
·
31 cleared
·
Since 1985
32
Total
31
Cleared
0
Denied
27
devices
26-27 of 27
Filters
1
2
Cleared
Nov 04, 1986
EUP-012I, EUP-012J & EUB-0124 ULTRASONIC SCANNER
K862164
·
IYO
Radiology
·
151d
Cleared
Feb 25, 1985
EUB-40
K844128
·
JAF
Radiology
·
125d
1
2
Filters
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All
32
Radiology
27
Cardiovascular
4
Obstetrics & Gynecology
1