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510(k) K082005

MODIFICATION TO HI-ART TREATMENT SYSTEM by Tomotherapy Incorporated — Product Code MUJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2008
Date Received
July 14, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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 Tomotherapy Incorporated

  • K112776 — TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZER (December 22, 2011)
  • K112446 — TOMOTHERAPY TREATMENT SYSTEM (October 7, 2011)
  • K060912 — MODIFICATION TO: HI-ART SYSTEM (April 19, 2006)
  • K042739 — HI-ART SYSTEM (November 3, 2004)
  • K033347 — MODIFICATION TO: HI-ART SYSTEM (November 12, 2003)

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