FDA 510(k) Application Details - K061302

Device Classification Name Camera, Multi Format, Radiological

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510(K) Number K061302
Device Name Camera, Multi Format, Radiological
Applicant MITSUBISHI ELECTRIC CORPORATION KYOTO WORKS
319 AKENO, OBATA-CHO
ISE-SHI MIE-KEN JP
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Contact SHINICHI YAMANAKA
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Regulation Number 892.2040

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Classification Product Code LMC
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Date Received 05/10/2006
Decision Date 06/23/2006
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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