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510(k) K982427

TREX TILT C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING SYSTEM, TREX TILT-C by Trex Medical Corp. — Product Code OWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1998
Date Received
July 13, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Interventional Fluoroscopic X-Ray System
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

Interventional fluoroscopy

Other clearances by Trex Medical Corp.

  • K992229 — MXU-125 OR TMX-125 (August 6, 1999)
  • K984092 — PROFILE 2000 MAMMOGRAPHY SYSTEM, PRO-2000 (February 5, 1999)
  • K984091 — CONTOUR 2000 MAMMOGRAPHY SYSTEM, MODEL CTR- 2000 (February 5, 1999)
  • K984414 — XRE COLLIMATOR WITH SPECTRAL FILTER (December 30, 1998)
  • K982120 — DIGITAL IMAGING SYSTEM, MODELS DIGITREX-1000 AND DIGITREX-2000 (DIGITREX-X000 FA (September 10, 1998)

Other clearances for product code OWB

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  • K251827 — Azurion R3.1 (October 24, 2025)
  • K251602 — Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (October 10, 2025)