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FDA 510(k) Application Details - K171175
Device Classification Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
More FDA Info for this Device
510(K) Number
K171175
Device Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant
Imaging Dynamics Company Ltd.
#130, 5310-29th Street NE
Calgary T1Y 7E5 CA
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Contact
Nicole Wherry
Other 510(k) Applications for this Contact
Regulation Number
892.1650
More FDA Info for this Regulation Number
Classification Product Code
MQB
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More FDA Info for this Product Code
Date Received
04/21/2017
Decision Date
10/05/2017
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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