FDA 510(k) Application Details - K171716

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

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510(K) Number K171716
Device Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant Konica Minolta, Inc.
1 Sakura-machi
Hino-shi 191-8511 JP
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Contact Tsutomu Fukui
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Regulation Number 892.1650

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Classification Product Code MQB
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Date Received 06/09/2017
Decision Date 08/25/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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