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FDA 510(k) Application Details - K042428
Device Classification Name
System, Tomography, Computed, Emission
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510(K) Number
K042428
Device Name
System, Tomography, Computed, Emission
Applicant
HITACHI MEDICAL SYSTEMS AMERICA, INC.
1959 SUMMIT COMMERCE PARK
TWINSBURG, OH 44087 US
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Contact
DOUGLASS THISTLETHWAITE
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Regulation Number
892.1200
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Classification Product Code
KPS
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More FDA Info for this Product Code
Date Received
09/08/2004
Decision Date
09/17/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
Y
Expedited Review
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