Precision Rxi Analog and Digital X-Ray Systems

Q: What is the product code of K082243?

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) K082243 · General Medical Merate S.P.A

Substantially Equivalent

510(k) numberK082243

Submission

Device name: Precision Rxi Analog and Digital X-Ray Systems
Applicant: General Medical Merate S.P.A
Greenwood Village, CO, US
Received: August 7, 2008
Decision date: November 7, 2008
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement 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
K213081	CLISIS SYSTEMS, Discovery RF180IZF · Traditional	10/26/2021SE
K173395	MECALL CLISIS SYSTEMS, Discovery RF180JAA · Special	05/21/2018SE
K140380	Opera SwingJAA · Traditional	09/26/2014SE
K041605	Precision Rxi Analog X-Ray SystemOWB · Traditional	06/30/2004SE
K881386	X-Ray Generating System TF 1000IZO · Traditional	07/08/1988SE
K827993	MTH C/A Mobile C Arm · Traditional	09/13/1982SE

Questions and answers

When was Precision Rxi Analog and Digital X-Ray Systems cleared by the FDA?

Precision Rxi Analog and Digital X-Ray Systems (K082243) received a 510(k) decision of Substantially Equivalent on November 7, 2008, 92 days after the submission was received.

What is the product code of K082243?

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