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510(k) K071701

TRACKLEAF-10 by Direx Systems Corp. — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 2007
Date Received
June 21, 2007
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 Direx Systems Corp.

  • K111947 — DUET MAGNA (March 1, 2012)
  • K102765 — PRONEX (December 7, 2010)
  • K072529 — TRACKPORT (October 26, 2007)
  • K063482 — CROSSPLAN / ACCUSOFT-XL V.4.04 (December 14, 2006)
  • K062147 — INTEGRA SL (October 20, 2006)
  • K062032 — ACCUSOFT, ACCUSOFT XL (October 5, 2006)
  • K061873 — VERT-X (August 18, 2006)
  • K061713 — MAGIS1;MAGIS2 (July 21, 2006)
  • K052212 — MIGUE (March 10, 2006)
  • K053640 — INTEGRA (March 1, 2006)

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