Home / 510(k) Clearances / K251602

510(k) K251602

Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging by Canon Medical Systems Corporation — Product Code OWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2025
Date Received
May 27, 2025
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 Canon Medical Systems Corporation

  • K260078 — Aquilion ServeSP (TSX-307B) V2.0 (March 13, 2026)
  • K253584 — Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) (March 10, 2026)
  • K253597 — Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System (January 20, 2026)
  • K251370 — Cartesion Prime (PCD-1000A/3) V10.21 (December 1, 2025)
  • K252074 — Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System (October 31, 2025)
  • K251645 — Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S (September 26, 2025)
  • K250901 — Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing (July 22, 2025)
  • K243398 — CT Scanner TSX-501R/1 V11.1 (June 20, 2025)
  • K242808 — Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5 (May 13, 2025)
  • K250328 — UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program (April 30, 2025)

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)
  • K251523 — Cios Spin (July 29, 2025)