FDA 510(k) Application Details - K032210

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

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510(K) Number K032210
Device Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant ALARA, INC.
2545 BARRINGTON CT.
HAYWARD, CA 94545-1134 US
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Contact DIANE M KING
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Regulation Number 892.1650

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Classification Product Code MQB
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Date Received 07/21/2003
Decision Date 10/02/2003
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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