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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 K991129
Device Name HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICK NAL(TI) CRYSTAL
Applicant
Hitachi Medical Corp. of America
9177 Dutton Dr.
Twinsburg,  OH  44056
Applicant Contact GARY W ENOS
Correspondent
Hitachi Medical Corp. of America
9177 Dutton Dr.
Twinsburg,  OH  44056
Correspondent Contact GARY W ENOS
Regulation Number892.1200
Classification Product Code
KPS  
Date Received04/02/1999
Decision Date 05/13/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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