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510(k) K061873

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

K061873 is an FDA 510(k) premarket notification submitted by Direx Systems Corp. for the device "VERT-X". The FDA issued a decision of Substantially Equivalent on August 18, 2006. The device falls under product code OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile), a Class II device regulated under 21 CFR 892.1650. Direx Systems Corp. has at least 10 other 510(k) clearances on record.

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)

Other clearances for product code OXO

  • K253296 — Digital C-ARM with 3D (June 5, 2026)
  • K252579 — Orthoscan TAU MVP Mini C-Arm System (January 14, 2026)
  • K253269 — OEC One CFD (November 26, 2025)
  • K251004 — Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) (November 6, 2025)
  • K250587 — Orthoscan TAU Mini C-Arm (July 2, 2025)
  • K243452 — Orthoscan VERSA Mini C-Arm (January 14, 2025)
  • K240828 — OEC One ASD (December 27, 2024)
  • K233669 — OEC 3D (March 28, 2024)
  • K213113 — Orthoscan Tau Mini C-Arm (October 21, 2021)
  • K203346 — OEC 3D (March 5, 2021)

FDA data resources