510(k) · Cleared
ClearedCereMetrix Silver
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ceremetrix Corp · LLZ System, Image Processing, Radiological
Cleared on Feb 28, 2018 after a 152-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Feb 28, 2018
- Review
- 152 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLZ device
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What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
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…
Read the full statement (238 words)
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,
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K173145 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173145: CereMetrix Silver.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173145
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026