Home / 510(k) Clearances / K243432

510(k) K243432

Vascular Navigation PAD 2.0; Navigation Software Vascular PAD by Brainlab AG — Product Code OWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2025
Date Received
November 5, 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 Brainlab AG

  • K252476 — Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements View (October 16, 2025)
  • K252562 — Spine & Trauma Navigation Instruments (September 12, 2025)
  • K243142 — Cranial 4Pi Immobilization (June 23, 2025)
  • K250440 — RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (June 17, 2025)
  • K243633 — Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements (June 13, 2025)
  • K243810 — TraumaCad Neo (1.1) (June 4, 2025)
  • K242569 — Mixed Reality Spine Navigation (May 16, 2025)
  • K243698 — Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignm (January 28, 2025)
  • K240431 — ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface (July 24, 2024)
  • K240701 — Drill Guide; Drill Bit; Spine & Trauma Navigation (May 23, 2024)

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)