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U.S. Department of Health and Human Services

510(k) Premarket Notification
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ProductCode: LNH Applicant: HITACHI MEDICAL SYSTEMS AMERICA, INC Decision Date To: 10/20/2014
 
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version 5 operating system software HITACHI MEDICAL SYSTEMS AMERICA, INC. K943799 12/09/1994
version 4 operating system software HITACHI MEDICAL SYSTEMS AMERICA, INC. K971279 07/03/1997
version 3.7 operating system software HITACHI MEDICAL SYSTEMS AMERICA, INC. K960181 03/05/1996
version 3 operating system software HITACHI MEDICAL SYSTEMS AMERICA, INC. K935670 03/30/1994
trillium oval v 5.1 mri system HITACHI MEDICAL SYSTEMS AMERICA, INC. K160152 05/20/2016
trillium oval mr system HITACHI MEDICAL SYSTEMS AMERICA, INC. K142734 03/02/2015
stratis ii HITACHI MEDICAL SYSTEMS AMERICA, INC. K974498 02/26/1998
stratis HITACHI MEDICAL SYSTEMS AMERICA, INC. K945386 03/21/1995
quad pelvis coil HITACHI MEDICAL SYSTEMS AMERICA, INC. K943321 09/23/1994
qd bilateral breast coil HITACHI MEDICAL SYSTEMS AMERICA, INC. K953262 10/17/1995
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