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FDA 510(k) Application Details - K172863
Device Classification Name
More FDA Info for this Device
510(K) Number
K172863
Device Name
Infinix-i, INFX-8000V, V7.0
Applicant
Toshiba Medical Systems Corporation
1385 Shimoishigami
Otawara-shi 324-8550 JP
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Contact
Paul Biggins
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Regulation Number
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Classification Product Code
OWB
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More FDA Info for this Product Code
Date Received
09/20/2017
Decision Date
12/14/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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