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FDA 510(k) Application Details - K051418
Device Classification Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
More FDA Info for this Device
510(K) Number
K051418
Device Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant
KONICA MINOLTA MEDICAL & GRAPHIC, INC.
319 AKENO, OBATA-CHO
WATARAI-GUN
MIE-KEN 519-05 JP
Other 510(k) Applications for this Company
Contact
SHINICHI MAMANAKA
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
06/01/2005
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
Special
Reviewed By Third Party
N
Expedited Review
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