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FDA 510(k) Application Details - K063039
Device Classification Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
More FDA Info for this Device
510(K) Number
K063039
Device Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant
IMAGING DYNAMICS COMPANY LTD.
151,2340 PEGASUS WAY, NE
CALGARY, ALBERTA T2E 8M5 CA
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Contact
SHIRANTHA SAMARAPPULI
Other 510(k) Applications for this Contact
Regulation Number
892.1650
More FDA Info for this Regulation Number
Classification Product Code
MQB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/03/2006
Decision Date
11/02/2006
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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