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510(k) Data Aggregation
K Number
K112570Device Name
CENTRICITY CARDIO IMAGING
Manufacturer
GE HEALTHCARE INTEGRATED IT SOLUTIONS
Date Cleared
2011-11-30
(85 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
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Matched: '872.2050'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Centricity* Cardio Imaging is a software only Picture Archiving and Communication System (PACS). It will be sold as a software only device to operate on general purpose computing hardware. Centricity* Cardio Imaging receives medical images and other information from various data sources. Information can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Centricity* Cardio Imaging is intended to assist trained professionals in the viewing, analysis, and diagnostic interpretation of images and other information for the diagnosis and treatment of cardiac and vascular disease. These trained professionals include but are not limited to physicians, cardiologists, radiologists, nurses, medical technicians, and assistants.
Device Description
Centricity* Cardio Imaging is a web enabled cardiology Picture Archiving and Communication System that offers highly integrated imaging, workflow and information management in a single platform. Centricity* Cardio Imaging leverages a rich ECHO/NIPV clinical toolset and the data management capability from its predicate devices.
Centricity* Cardio Imaging is a software only medical device comprised of a client and server. The client is web-accessed and provides the user-facing functions such as the work list, viewing, and reporting. The server provides background functions such as data storage, data transfer, database management, application deployment, user authentication, user profiles, licensing, and hanging protocols.
Centricity* Cardio Imaaina is a software only medical device intended for use with commercially available off the shelf hardware.
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K Number
K970116Device Name
ESG-1 ELECTROSONOGRAM (ESG-1)
Manufacturer
MYO-TRONICS, INC.
Date Cleared
1997-04-02
(79 days)
Product Code
NFQ
Regulation Number
872.2050Why did this record match?
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Matched: '872.2050'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ELECTROSONOGRAM ESC-I is a non-invasive device that measures and records sounds enitted from the temporomandibular (jaw) joint along with the relative position of the jaw as a means of assessing the status of the temporomandibular joint.
Device Description
ESG-1 Electrosonogram is a non-invasive device that measures and records sounds emitted from the temporomandibular joint along with the relative position of the jaw as a means of assessing the status of the temporomandibular joint.
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