FDA 510(k) Application Details - K051418

Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)

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510(K) Number K051418
Device Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant KONICA MINOLTA MEDICAL & GRAPHIC, INC.
319 AKENO, OBATA-CHO
WATARAI-GUN
MIE-KEN 519-05 JP
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Contact SHINICHI MAMANAKA
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Regulation Number 892.1650

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Classification Product Code MQB
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Date Received 06/01/2005
Decision Date 07/01/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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