# K173145: CereMetrix Silver

- Pathway: 510(k) (Traditional)
- Applicant: Ceremetrix Corp
- Decided: Feb 28, 2018 after 152 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The CereMetrix Silver software is used by trained medical professionals as a tool to aid in evaluation and information management of digital medical images. The brain 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 full 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,

Source page: https://510kreport.com/device/K173145
Methodology: https://510kreport.com/methodology