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FDA 510(k) Application Details - K121109
Device Classification Name
System, X-Ray, Stationary
More FDA Info for this Device
510(K) Number
K121109
Device Name
System, X-Ray, Stationary
Applicant
KONICA MINOLTA MEDICAL & GRAPHIC, INC.
NO. 1 SAKURA-MACHI, HINO-SHI
TOKYO 191-8511 JP
Other 510(k) Applications for this Company
Contact
SHIGEYUKI KOJIMA
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
04/12/2012
Decision Date
05/23/2012
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
Y
Expedited Review
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