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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K954143
Device Name HITACHI SPECTRADIGITAL SERIES GAMMA CAMERA SYSTEMS
Applicant
Hitachi Medical Corp. of America
660 White Plains Rd.
Tarrytown,  NY  10591
Applicant Contact GARY W ENOS
Correspondent
Hitachi Medical Corp. of America
660 White Plains Rd.
Tarrytown,  NY  10591
Correspondent Contact GARY W ENOS
Regulation Number892.1200
Classification Product Code
KPS  
Date Received09/01/1995
Decision Date 12/22/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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