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510(k) K243376

uAngio AVIVA CX by Shanghai United Imaging Healthcare Co., Ltd. — Product Code OWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2025
Date Received
October 30, 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 Shanghai United Imaging Healthcare Co., Ltd.

  • K253564 — uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo (February 13, 2026)
  • K253173 — uCT 780 with uWS-CT-Dual Energy Analysis (January 20, 2026)
  • K252000 — uDR Arria & uDR Aris (November 26, 2025)
  • K252371 — uMR 680 (September 25, 2025)
  • K250045 — uWS-Angio Pro (September 24, 2025)
  • K251167 — uDR Aurora CX (September 19, 2025)
  • K250040 — uWS-Angio (September 12, 2025)
  • K250246 — uMR Jupiter (August 5, 2025)
  • K251839 — uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) (July 17, 2025)
  • K243547 — uMR Ultra (July 17, 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)
  • K251602 — Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (October 10, 2025)