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FDA 510(k) Application Details - K042791
Device Classification Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
More FDA Info for this Device
510(K) Number
K042791
Device Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant
ANN ARBOR DIGITAL DEVICES
699 SKYNOB COURT
ANN ARBOR, MI 48105 US
Other 510(k) Applications for this Company
Contact
WILLIAM J O'NEILL
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
10/07/2004
Decision Date
07/01/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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