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FDA 510(k) Application Details - K024284
Device Classification Name
Accelerator, Linear, Medical
More FDA Info for this Device
510(K) Number
K024284
Device Name
Accelerator, Linear, Medical
Applicant
SYNCOR RADIATION MANAGEMENT
6045 COCHRAN RD.
SOLON, OH 44139-3303 US
Other 510(k) Applications for this Company
Contact
CHRISTINE G CASTLEBERRY
Other 510(k) Applications for this Contact
Regulation Number
892.5050
More FDA Info for this Regulation Number
Classification Product Code
IYE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/23/2002
Decision Date
03/11/2003
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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