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2015
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794
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788
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740
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721
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510k Database
Manufacturers
US
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
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32
Radiology
27
Cardiovascular
4
Obstetrics & Gynecology
1