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CereMetrix Silver

by Ceremetrix Corp

510(k) K173145

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK173145 Date28 Feb 2018ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

CereMetrix Silver is a Class II X-ray system used in radiology. It is a software tool designed to aid in the evaluation and information management of digital medical image modalities including SPECT, PET, MRI, and CT as supported by ACR/NEMA DICOM 3.0.

The device is supplied as software for use by trained medical professionals. It received FDA 510(k) clearance under K-number K173145 on February 28, 2018, and is classified under product code LLZ.

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is CereMetrix Silver used for?

    CereMetrix Silver is a software tool designed to aid in the evaluation and information management of digital medical image modalities including SPECT, PET, MRI, and CT as supported by ACR/NEMA DICOM 3.0, used by trained medical professionals in radiology.

  • How is CereMetrix Silver supplied and who uses it?

    The device is supplied as software for use by trained medical professionals, requiring no physical hardware beyond standard imaging systems that support DICOM 3.0 compatibility.

  • What regulatory clearance does CereMetrix Silver have?

    CereMetrix Silver received FDA 510(k) clearance under K-number K173145 on February 28, 2018, and is classified under product code LLZ as a substantially equivalent device.