Home / 510(k) Clearances / K240465

510(k) K240465

O-arm O2 Imaging System by Medtronic Navigation, Inc. — Product Code OWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2024
Date Received
February 16, 2024
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 Medtronic Navigation, Inc.

  • K253391 — Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Appli (March 13, 2026)
  • K253381 — Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application (February 12, 2026)
  • K251282 — StealthStation S8 Spine Software (October 17, 2025)
  • K242464 — Stealth™ Spine Clamps; ModuLeX™ Shank Mounts (June 5, 2025)
  • K250307 — Visualase V2 MRI-guided Laser Ablation System (9736422) (May 29, 2025)
  • K231976 — StealthStation Cranial Software, v3.1.5 (9735585) (October 19, 2023)
  • K221087 — Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4 (June 10, 2022)
  • K211269 — Visualase MRI-Guided Laser Ablation System (SW 3.4) (January 7, 2022)
  • K212397 — StealthStation S8 Cranial v2.0 (December 22, 2021)
  • K211442 — StealthStation Spinous Process Clamps (July 8, 2021)

Other clearances for product code OWB

  • K253584 — Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) (March 10, 2026)
  • K252500 — CARA System (February 20, 2026)
  • 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)