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Syngo.X

by Siemens AG Medical Solutions 510(k)

Active United States

510(k) K092519

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK092519 Date27 Aug 2009ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

4 recalls · FDA

    • Terminated Z-1688-2017 FDA Class II initiated 6 Mar 2017

    Software changes now available to address several issues

    • Terminated Z-2852-2016 FDA Class II initiated 5 Aug 2016

    Software error. Incorrect values for the volume calculation from a freehand VOI at the customer site. In volume calculations of prostate as well as in volume calculations of liver were too high.

    • Terminated Z-2245-2016 FDA Class II initiated 23 Jun 2016

    Incorrect values for the volume calculation. Software update VB30B via Update Instructions SY018/16/P to resolve software errors.

    • Terminated Z-1705-2015 FDA Class II initiated 15 May 2015

    measurements drawn on the 2nd and subsequent images of the series are not visible on printouts when the series is sent to print.

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, 24 Sep 2026

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

Syngo.X is a radiology information system (RIS) designed to support radiological workflow from order entry to image and report distribution. It enables the use of smart workflow-improving solutions such as role-based syngo Portals, syngo Chorus MR, and syngo Speech Recognition applications.

The device is supplied as a software system for use in healthcare settings, supporting task-oriented worklists and shared server concepts to increase efficiency and reduce costs. It received FDA 510(k) clearance (K092519) as substantially equivalent to a predicate device, with authorization under product code LLZ and review by the Radiology advisory committee.

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Questions

AI-generated answers, 24 Sep 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 Syngo.X used for in a healthcare setting?

    Syngo.X is a radiology information system designed to support radiological workflow from order entry to image and report distribution, enabling task-oriented worklists and shared server concepts to increase efficiency and reduce costs.

  • How is Syngo.X supplied and deployed in clinical environments?

    Syngo.X is supplied as a software system for use in healthcare settings, supporting role-based syngo Portals, syngo Chorus MR, and syngo Speech Recognition applications to improve workflow efficiency.

  • What regulatory pathway was used for Syngo.X's market authorization?

    Syngo.X received FDA 510(k) clearance (K092519) as substantially equivalent to a predicate device, with authorization under product code LLZ and review by the Radiology advisory committee.