FDA 510(k) Application Details - K042755

Device Classification Name System, Image Processing, Radiological

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510(K) Number K042755
Device Name System, Image Processing, Radiological
Applicant EIZO NANAO CORPORATION
153 SHIMOKASHIWANO-CHO
MATTO-SHI
ISHIKAWA-KEN 924-8566 JP
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Contact HIROAKI HASHIMOTO
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 10/04/2004
Decision Date 02/10/2005
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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