uMC 560i

FDA 510(k) K183144 · Shanghai United Imaging Healthcare Co., Ltd.

Substantially Equivalent

510(k) numberK183144

Submission

Device name
uMC 560i
Applicant
Shanghai United Imaging Healthcare Co., Ltd.
Shanghai, CN
Received
November 13, 2018
Decision date
December 19, 2019
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

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K253726uAngio AVIVA CXOWB · Traditional Shanghai United Imaging Healthcare Co., Ltd.08/21/2026SE
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

More from Genoray Co., Ltd.

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K253726uAngio AVIVA CXOWB · Traditional 08/21/2026SE
K261427uMI Panvivo (uMI Panvivo M)KPS · Traditional 07/28/2026SE
K260113uMR AstraLNH · Traditional 05/22/2026SE
K253077uOmnispace.MRQIH · Traditional 04/22/2026SE
K260524uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)…KPS · Traditional 04/03/2026SE
K253564uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX)…KPS · Traditional 02/13/2026SE
K253173uCT 780 with uWS-CT-Dual Energy AnalysisJAK · Traditional 01/20/2026SE
K252000uDR Arria & uDR ArisKPR · Traditional 11/26/2025SE
K252371uMR 680LNH · Special 09/25/2025SE
K250045uWS-Angio ProLLZ · Traditional 09/24/2025SE

Questions and answers

When was uMC 560i cleared by the FDA?

uMC 560i (K183144) received a 510(k) decision of Substantially Equivalent on December 19, 2019, 401 days after the submission was received.

What is the product code of K183144?

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