FDA 510(k) Application Details - K071181

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

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510(K) Number K071181
Device Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant KONICA MINOLTA MEDICAL & GRAPHIC, INC.
140 EAST 45TH ST., 25TH FLOOR
TWO GRAND CENTRAL TOWER
NEW YORK, NY 10017 US
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Contact RUSSEL MUNVES
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Regulation Number 892.1650

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Classification Product Code MQB
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Date Received 04/30/2007
Decision Date 05/30/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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