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510(k) K183109

ControlRad Trace Model 8 by Controlrad, Inc. — Product Code OWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2019
Date Received
November 8, 2018
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 Controlrad, Inc.

  • K213455 — ControlRad Select Model Z (November 24, 2021)
  • K211782 — ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9 (July 1, 2021)
  • K202431 — ControlRad Select Model Z (December 23, 2020)
  • K200663 — ControlRad Trace Model 9 (June 24, 2020)
  • K200238 — ControlRad Sterile Cover (April 26, 2020)

Other clearances for product code OWB

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  • K251992 — ArmSure Fluoroscopic Positioning System (February 11, 2026)
  • K254186 — Azurion R3.1 (January 16, 2026)
  • K252068 — MC2 Portable X-ray System (December 22, 2025)
  • K251893 — SKAN C PULSAR (December 16, 2025)
  • K251199 — Allia Moveo (December 9, 2025)
  • K250241 — Cios Select (November 4, 2025)
  • K251827 — Azurion R3.1 (October 24, 2025)
  • K251602 — Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (October 10, 2025)