Home / 510(k) Clearances / K900194

510(k) K900194

MTHF-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT by Imt America, Inc. — Product Code OXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 1990
Date Received
January 16, 1990
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 Imt America, Inc.

  • K903921 — MTE-T RADIOGRPHIC/TOMOGRAPHIC ELEVATING TABLE (December 4, 1990)
  • K901654 — MTT 90 UNIVERSAL REMOTE-CONTROLLED X-RAY TABLE (November 23, 1990)
  • K903422 — MT-15 RADIOGRAPHIC/FLUOROSCOPIC TILT TABLE (September 4, 1990)
  • K900193 — MTHF-9R MOBIL C-ARM IMAGE INTENSIFIER UNIT (May 9, 1990)

Other clearances for product code OXO

  • 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)
  • K192819 — OEC Elite (November 8, 2019)