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510(k) K082221

RAYDOSE by Raysearch Laboratories AB — Product Code MUJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 2008
Date Received
August 6, 2008
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

Other clearances by Raysearch Laboratories AB

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  • K100552 — RAYSTATION VERSION 1.0 (March 12, 2010)
  • K083264 — RAYAUTOPLAN 1.0 (January 22, 2009)

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