FDA 510(k) Applications for Medical Device Product Code: OEB (Lung Computed Tomography System, Computer-Aided Detection)

FDA 510(k) Applications for Medical Device Product Code "OEB"
(Lung Computed Tomography System, Computer-Aided Detection)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K192880	Beijing Infervision Technology Co.,Ltd.	InferRead Lung CT.AI	07/02/2020
K221592	Coreline Soft Co.,Ltd.	AVIEW Lung Nodule CAD	02/24/2023
K042694	GE MEDICAL SYSTEMS	ADVANCED LUNG ANALYSIS II	11/18/2004
K043617	HOLOGIC, INC.	IMAGECHECKER CT CAD SOFTWARE SYSTEM	12/21/2007
K041807	MEDICSIGHT	LUNG CAR 1.1	07/22/2004
K033412	MEDICSIGHT	MEDICLUNG, RELEASE 1	12/30/2003
K201501	MeVis Medical Solutions AG	Veolity	02/23/2021
K041380	R2 TECHNOLOGY, INC.	IMAGECHECKER-CT SOFTWARE PACKAGE WITH FILLING DEFECT INDICATOR	06/08/2004
K221612	Riverain Technologies, Inc.	ClearRead CT	12/05/2022
K161201	RIVERAIN TECHNOLOGIES, LLC	ClearRead CT	09/09/2016
K143196	SIEMENS AG MEDICAL SOLUTIONS	syngo.CT Lung CAD	05/12/2015
K033374	SIEMENS AG, MEDICAL SOLUTIONS	LUNGCARE CT SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY	11/06/2003
K203258	Siemens Healthcare GmbH	syngo.CT Lung CAD	03/31/2021
K231157	Siemens Healthcare GmbH	syngo.CT Lung CAD (Version VD30)	07/19/2023
K063877	SIEMENS MEDICAL SOLUTIONS USA, INC.	SYNGO LUNG CAD	10/18/2006
K193216	Siemens Medical Solutions, Inc	syngo.CT Lung CAD	03/09/2020