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FDA 510(k) Application Details - K062405
Device Classification Name
System, X-Ray, Stationary
More FDA Info for this Device
510(K) Number
K062405
Device Name
System, X-Ray, Stationary
Applicant
IMAGING DYNAMICS COMPANY LTD.
151,2340 PEGASUS WAY, NE
CALGARY, ALBERTA T2E 8M5 CA
Other 510(k) Applications for this Company
Contact
SHIRANTHA SAMARAPPULI
Other 510(k) Applications for this Contact
Regulation Number
892.1680
More FDA Info for this Regulation Number
Classification Product Code
KPR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/15/2006
Decision Date
09/13/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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