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510(k) K041213

3DSCOPE by Direx Systems Corp. — Product Code OXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2004
Date Received
May 10, 2004
Clearance Type
Special
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)
  • K061873 — VERT-X (August 18, 2006)
  • K061713 — MAGIS1;MAGIS2 (July 21, 2006)
  • K052212 — MIGUE (March 10, 2006)

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