FDA 510(k) Application Details - K171222

Device Classification Name System, Image Processing, Radiological

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510(K) Number K171222
Device Name System, Image Processing, Radiological
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 892.2050

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Classification Product Code LLZ
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Date Received 04/26/2017
Decision Date 06/08/2017
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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