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FDA 510(k) Application Details - K003438
Device Classification Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
More FDA Info for this Device
510(K) Number
K003438
Device Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant
CMT MEDICAL TECHNOLOGIES, LTD.
MATAM HIGH TECHNOLOGY CENTER
HAIFA 31905 IL
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Contact
YESHAYAHU RAZ
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
11/06/2000
Decision Date
07/03/2001
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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