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510(k) K033347

MODIFICATION TO: HI-ART SYSTEM by Tomotherapy Incorporated — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 2003
Date Received
October 20, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accelerator, Linear, Medical
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)
  • K082005 — MODIFICATION TO HI-ART TREATMENT SYSTEM (August 25, 2008)
  • K060912 — MODIFICATION TO: HI-ART SYSTEM (April 19, 2006)
  • K042739 — HI-ART SYSTEM (November 3, 2004)

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