Allura Xper FD series and Allura Xper OR Table series

Q: What is the product code of K161563?

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

FDA 510(k) K161563 · Philips Medical Systems Nederland B.V.

Substantially Equivalent

510(k) numberK161563

Submission

Device name: Allura Xper FD series and Allura Xper OR Table series
Applicant: Philips Medical Systems Nederland B.V.
Best Noord-Brabant, NL
Received: June 6, 2016
Decision date: July 29, 2016
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)	Device	Applicant	Decision
K253726	uAngio AVIVA CXOWB · Traditional	Shanghai United Imaging Healthcare Co., Ltd.	08/21/2026SE
K261413	Extron 3;EXTRON 6OWB · Traditional	DRTECH Corporation	08/19/2026SE
K254205	Zenition 30OWB · Traditional	Philips Medical Systems Nederland B.V.	08/07/2026SE
K260607	Shield System (Siemens 30x40)OWB · Special	Radiaction , Ltd.	07/31/2026SE
K253670	SmartCT (R3.0 (L10))OWB · Abbreviated	Philips Medical Systems B.V.	07/10/2026SE
K252735	C-beamOWB · Traditional	Pulmera, Inc.	05/22/2026SE
K252503	Intelligent NROWB · Traditional	Canon, Inc.	04/30/2026SE
K254173	ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoOWB · Traditional	Siemens Medical Solutions USA, Inc.	04/24/2026SE
K253752	ARTIS genio floor; ARTIS icono.explore floorOWB · Traditional	Siemens Medical Solutions USA, Inc.	04/23/2026SE
K252229	Belliger AceOWB · Traditional	Genoray Co., Ltd.	04/02/2026SE

More from Genoray Co., Ltd.

510(k)	Device	Decision
K254205	Zenition 30OWB · Traditional	08/07/2026SE
K262330	dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil…MOS · Special	07/30/2026SE
K262294	dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes…MOS · Special	07/24/2026SE
K260207	Multimodality Simulation Workspace (MM Sim) (v1.0.0)MUJ · Traditional	05/27/2026SE
K253614	EchoNavigator R5.0QIH · Traditional	03/17/2026SE
K260169	AV Cardiac CTJAK · Traditional	03/05/2026SE
K253648	Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR…LNH · Abbreviated	02/23/2026SE
K253735	AV VascularQIH · Traditional	01/22/2026SE
K254190	dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0TMOS · Special	01/14/2026SE
K252645	LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D HubDQK · Abbreviated	10/24/2025SE

Questions and answers

When was Allura Xper FD series and Allura Xper OR Table series cleared by the FDA?

Allura Xper FD series and Allura Xper OR Table series (K161563) received a 510(k) decision of Substantially Equivalent on July 29, 2016, 53 days after the submission was received.

What is the product code of K161563?

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