FDA 510(k) Application Details - K023750

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

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510(K) Number K023750
Device Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant CANON U.S.A., INC.
ONE CANON PLAZA
LAKE SUCCESS, NY 11042-1198 US
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Contact SHEILA DRISCOLL
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Regulation Number 892.1650

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Classification Product Code MQB
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Date Received 11/08/2002
Decision Date 11/22/2002
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 Y
Expedited Review



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