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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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More FDA Info for this Product Code
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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