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510(k) K221592

Device
AVIEW Lung Nodule CAD
Applicant
Coreline Soft Co., Ltd.
510(k) number
K221592
Product code
OEB
Decision
Substantially Equivalent (SESE)
Decision date
2023-02-24
Date received
2022-06-02
Regulation
892.2050
Classification name
Lung Computed Tomography System, Computer-Aided Detection
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Hyeyi Park
Address
4, 5f (Yeonnam-Dong), 49 World Cup Buk-Ro 6-Gil, Mapo-Gu Seoul KR 03991 03991

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OEB#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K254075Synapse Lung Nodule AIFujifilm Corporation2026-05-27
K251203AVIEW Lung Nodule CADCoreline Soft Co., Ltd.2025-12-03
K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.2025-05-16
K242919V5med Lung AIV5med, Inc.2025-03-27
K231157syngo.CT Lung CAD (Version VD30)Siemens Healthcare GmbH2023-07-19
K221612ClearRead CTRiverain Technologies, Inc.2022-12-05
K203258syngo.CT Lung CADSiemens Healthcare GmbH2021-03-31
K201501VeolityMeVis Medical Solutions AG2021-02-23
K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.2020-07-02
K193216syngo.CT Lung CADSiemens Medi Cal Solutions, Inc.2020-03-09
K161201ClearRead CTRiverain Technologies, LLC2016-09-09
K143196syngo.CT Lung CADSiemens AG Medical Solutions2015-05-12
K043617IMAGECHECKER CT CAD SOFTWARE SYSTEMHologic, Inc.2007-12-21
K063877SYNGO LUNG CADSiemens Medical Solutions USA, Inc.2006-10-18
K042694ADVANCED LUNG ANALYSIS IIGE Medical Systems2004-11-18