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FDA 510(k) Application Details - K073670
Device Classification Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
More FDA Info for this Device
510(K) Number
K073670
Device Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant
OREX COMPUTED RADIOGRAPHY LTD
STAR YOKNEAM BLDG
P.O. BOX 505
YOKNEAM 20692 IL
Other 510(k) Applications for this Company
Contact
DAN LAOR
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
12/27/2007
Decision Date
01/25/2008
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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