FDA 510(k) Application Details - K072065

Device Classification Name System, Image Processing, Radiological

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510(K) Number K072065
Device Name System, Image Processing, Radiological
Applicant TOTOKU ELECTRIC CO., LTD
300 OYA
UEDA, NAGANO 386-0192 JP
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Contact MIKIO HASEGAWA
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 07/27/2007
Decision Date 08/14/2007
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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