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510(k) K100552

RAYSTATION VERSION 1.0 by Raysearch Laboratories AB — Product Code MUJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 2010
Date Received
February 26, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Planning, Radiation Therapy Treatment
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

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