Home / 510(k) Clearances / K211780

510(k) K211780

ZEN-2090 Turbo by Genoray Co., Ltd. — Product Code OWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 2022
Date Received
June 9, 2021
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 Genoray Co., Ltd.

  • K250060 — GT300; GT300-C (October 8, 2025)
  • K243420 — HESTIA (July 17, 2025)
  • K232085 — DVAS (DVAS-M, DVAS-W) (December 8, 2023)
  • K232158 — GenX-CR (September 13, 2023)
  • K230787 — Oscar 15 & Oscar 15i (July 20, 2023)
  • K220423 — PAPAYA & PAPAYA Plus (May 19, 2022)
  • K220392 — PAPAYA 3D & PAPAYA 3D Plus (May 19, 2022)
  • K200469 — PAPAYA 3D Premium & PAPAYA 3D Premium Plus (September 16, 2020)
  • K181943 — OSCAR (OSCAR Prime, OSCAR Classic) (August 17, 2018)
  • K172810 — PORT-X IV (March 7, 2018)

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)