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510(k) Data Aggregation
K Number
K173145Device Name
CereMetrix Silver
Manufacturer
Date Cleared
2018-02-28
(152 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
CereMetrix Corp
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The CereMetrix Silver software is used by trained medical professionals as a tool to aid in evaluation and information management of digital medical image modalities include SPECT, PET, MRI and CT as supported by ACR/NEMA DICOM 3.0. CereMetrix Silver assists in the following indications:
· Receive, transmit, store, retrieve, display, print, and process brain images and DICOM objects derived from radiological diagnostic systems, and processing workstations, among others.
· Create, display and print reports from medical images.
· Registration and review of brain images for diagnosis, treatment evaluation, and treatment planning.
· Localization and definition of objects and the differentiation between hyper or hypo perfused tissue, as compared to a composite average, in medical images.
· Creation of clusters for applications including quantitative analysis and archiving clusters for patient follow-up and management.
· CereMetrix Silver is capable of processing and displaying the brain image data in traditional formats, as well as pseudo three-dimensional renderings.
· CereMetrix Silver provides manual and automatic report creation plus the ability to view these reports remotely.
· CereMetrix Silver allows for quantitative and statistical analysis of SPECT brain scans by comparing to a composite average.
When used for diagnostic purposes, the mobile web client is not intended to replace a fill workstation and should only be used when there is no access to a workstation.
The software is not to be used for computer aided diagnostic purposes, including mammography CAD.
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