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510(k) Data Aggregation
K Number
K192880Device Name
InferRead Lung CT.AI
Manufacturer
Beijing Infervision Technology Co.,Ltd.
Date Cleared
2020-07-02
(267 days)
Product Code
OEB, LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Beijing Infervision Technology Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
InferRead Lung CT.AI is comprised of computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during the review of CT examinations of the chest on an asymptomatic population. InferRead Lung CT.AI requires that both lungs be in the field of view. InferRead Lung CT.AI provides adjunctive information and is not intended to be used without the original CT series.
Device Description
InferRead Lung CT.AI uses the Browser/Server architecture, and is provided as Service (SaaS) via a URL. The system integrates algorithm logic and database in the same the simplicity of the system and the convenience of system maintenance. The server is able to accept chest CT images from a PACS system, Radiological Information System) or directly from a CT scanner, analyze the images and provide output annotations regarding lung nodules. Users are an existing PACS system to view the annotations. Dedicated servers can be located at hospitals and are directly connected to the hospital networks. The software consists of 4 modules which are Image reception (Docking Toolbox), Image predictive processing (DLServer), Image storage (RePACS) and Image display (NeoViewer).
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