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510(k) Data Aggregation
K Number
K113442Device Name
3DI
Manufacturer
SHINA SYSTEMS LTD.
Date Cleared
2012-02-16
(87 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
SHINA SYSTEMS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
3Di is intended for use as an interactive tool for assisting professional Radiologists, Cardiologists and specialists to reach their own diagnosis, by providing tools of communication, clinics networking, WEB Serving, image viewing, image manipulation, 2D/3D image visualization, image processing, reporting and archiving. The 3Di indications for use are processing of Cardiac CT studies, including CT Calcium scoring, CT Cardiac angiography, coronaries analysis, cardiac functional assessment and of CT colonoscopy. The 3Di indications for use have been modified to include viewing of Mammography images.
Device Description
3Di is a PACS device which enables users to access medical images over a network and to utilize 3Di's image visualization tools to review the images. It provides the following functions: Web server, patient browser, PACS capabilities, multi-modality viewing, CT Cardiac and Colonoscopy clinical applications. The 3Di indications for use have been modified to include viewing of Mammography images.
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K Number
K112530Device Name
3DI INCLUDING CSCORE
Manufacturer
SHINA SYSTEMS LTD.
Date Cleared
2011-09-30
(30 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
SHINA SYSTEMS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
3Di is a software package of PACS workstation for handling multimodality (CT, XA, MR, PET, SPECT & Ultrasound) images, which are using DICOM protocol. It includes volume rendering, Multi-planar reconstruction (MPR) and viewing of the inner and outer surfaces of organs as well as within their walls.
3Di is intended for use as an interactive tool for assisting professional Radiologists, Cardiologists and specialists to reach their own diagnosis, by providing tools of communication, clinics networking, WEB Serving, image viewing, image manipulation, 2D/3D image visualization, image processing, reporting and archiving. This product is not intended for use with or for diagnostic interpretation of Mammography images.
The 3Di indications for use are processing of Cardiac CT studies, including CT Calcium scoring, CT Cardiac angiography, coronaries analysis, cardiac functional assessment and of CT colonoscopy.
Device Description
3Di is a PACS device which enables users to access medical images over a network and to utilize 3Di's image visualization tools to review the images. It provides the following functions: Web server, patient browser, PACS capabilities, multi-modality viewing, CT Cardiac and Colonoscopy clinical applications. The 3Di has been modified to include the 3Di CScore -option, which is intended to process CT cardiac studies for CT Calcium scoring.
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K Number
K093703Device Name
3DI
Manufacturer
SHINA SYSTEMS LTD.
Date Cleared
2010-01-19
(49 days)
Product Code
LLZ, CFR
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
SHINA SYSTEMS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
3Di is a software package of PACS workstation for handling multimodality (CT, XA, MR, PET, SPECT & Ultrasound) images, which are using DICOM protocol. It includes volume rendering, Multi-planar reconstruction (MPR) and viewing of the inner and outer surfaces of organs as well as within their walls.
3Di is intended for use as an interactive tool for assisting professional Radiologists, Cardiologists and specialists to reach their own diagnosis, by providing tools of communication, clinics networking, WEB Serving, image viewing, image manipulation, 2D/3D image visualization, image processing, reporting and archiving. This product is not intended for use with or for diagnostic interpretation of Mammography images.
The 3Di indications for use are processing of Cardiac CT angiography studies, including coronaries analysis, cardiac functional assessment and CT colonoscopy.
Device Description
3Di is a PACS device which enables users to access medical images over a network and to utilize 3Di's image visualization tools to review the images. It provides the following functions: Web server, patient browser, PACS capabilities, multi-modality viewing, CT Cardiac and Colonoscopy clinical applications.
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K Number
K070226Device Name
CARDIOCT
Manufacturer
SHINA SYSTEMS LTD.
Date Cleared
2007-03-09
(44 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
SHINA SYSTEMS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The system, which is comprised of diagnostic reading software, is intended for use by cardiologists and radiologists as an interactive tool for viewing and analyzing cardiac CT data for determining the presence and extent of coronary obstructive disease.
Device Description
The CardioCT (CCT) is a software application for viewing, evaluating and functionally analyzing cardiac CT images. The application is an interactive tool for radiologists and cardiologists and is used to visualize coronary anatomy, assess the state of the coronary arteries and execute functional analyses of the heart. This is accomplished by segmenting the heart tissues and coronary arteries and performing detailed evaluations of the coronary arteries and ventricular functions.
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