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FDA 510(k) Application Details - K223233
Device Classification Name
System,Planning,Radiation Therapy Treatment
More FDA Info for this Device
510(K) Number
K223233
Device Name
System,Planning,Radiation Therapy Treatment
Applicant
Elekta Solutions AB
Kungstensgatan 18 Box 7593
Stockholm SE10393 SE
Other 510(k) Applications for this Company
Contact
Melinda Smith
Other 510(k) Applications for this Contact
Regulation Number
892.5050
More FDA Info for this Regulation Number
Classification Product Code
MUJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/19/2022
Decision Date
02/23/2023
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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