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510(k) K061713

MAGIS1;MAGIS2 by Direx Systems Corp. — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 2006
Date Received
June 19, 2006
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)
  • K071701 — TRACKLEAF-10 (July 23, 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)
  • K052212 — MIGUE (March 10, 2006)
  • K053640 — INTEGRA (March 1, 2006)

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