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510(k) K042739

HI-ART SYSTEM by Tomotherapy Incorporated — Product Code MUJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 2004
Date Received
October 4, 2004
Clearance Type
Special
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

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  • 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)
  • K033347 — MODIFICATION TO: HI-ART SYSTEM (November 12, 2003)

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