uAngio AVIVA CX

FDA 510(k) K253726 · Shanghai United Imaging Healthcare Co., Ltd.

Substantially Equivalent

510(k) numberK253726

Submission

Device name
uAngio AVIVA CX
Applicant
Shanghai United Imaging Healthcare Co., Ltd.
Shanghai, CN
Received
November 24, 2025
Decision date
August 21, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OWB – Interventional Fluoroscopic X-Ray System
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1650
Specialty
Radiology

Interventional fluoroscopy

Other 510(k)s with product code OWB

510(k)DeviceApplicantDecision
K261413Extron 3;EXTRON 6OWB · Traditional DRTECH Corporation08/19/2026SE
K254205Zenition 30OWB · Traditional Philips Medical Systems Nederland B.V.08/07/2026SE
K260607Shield System (Siemens 30x40)OWB · Special Radiaction , Ltd.07/31/2026SE
K253670SmartCT (R3.0 (L10))OWB · Abbreviated Philips Medical Systems B.V.07/10/2026SE
K252735C-beamOWB · Traditional Pulmera, Inc.05/22/2026SE
K252503Intelligent NROWB · Traditional Canon, Inc.04/30/2026SE
K254173ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoOWB · Traditional Siemens Medical Solutions USA, Inc.04/24/2026SE
K253752ARTIS genio floor; ARTIS icono.explore floorOWB · Traditional Siemens Medical Solutions USA, Inc.04/23/2026SE
K252229Belliger AceOWB · Traditional Genoray Co., Ltd.04/02/2026SE
K252099TriniasOWB · Abbreviated Shimadzu Corporation03/24/2026SE

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Questions and answers

When was uAngio AVIVA CX cleared by the FDA?

uAngio AVIVA CX (K253726) received a 510(k) decision of Substantially Equivalent on August 21, 2026, 270 days after the submission was received.

What is the product code of K253726?

The FDA product code is OWB – Interventional Fluoroscopic X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1650.