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510(k) K061873

VERT-X by Direx Systems Corp. — Product Code OXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 2006
Date Received
July 3, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Image-Intensified Fluoroscopic X-Ray System, Mobile
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

Fluoroscopy of the human body.

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)
  • K061713 — MAGIS1;MAGIS2 (July 21, 2006)
  • K052212 — MIGUE (March 10, 2006)
  • K053640 — INTEGRA (March 1, 2006)

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