Syngo Multimodality Workplace (Syngo MM WP)

• • Terminated Z-0647-2009 FDA Unclassified (pre-2012) ·initiated 13 Nov 2008

  Indicated orientation does not match actual orientation of the patient.

510(k) Number

K052775 ↗

FDA Product Code

LLZ

Device Class

Class II

Regulation

21 CFR Part 892.2050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Syngo.CT Vascular Analysis

  Class II

  FDA 510(k) K112020 Active Cleared 18 Aug 2011

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  Class II

  FDA 510(k) K142628 Active Cleared 10 Oct 2014

• Syngo.VIA

  Class II

  FDA 510(k) K123920 Active Cleared 18 Jan 2013

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  Class II

  FDA 510(k) K093612 Active Cleared 4 Mar 2010

• Syngo Dynamics Version 7.0

  Class II

  FDA 510(k) K081018 Active Cleared 25 Apr 2008

• MOBILETT Impact

  Class II

  FDA 510(k) K231577 Active Cleared 25 Jul 2023

See all devices from Siemens Medi Cal Solutions, Inc. →

• What types of medical imaging data can the Syngo Multimodality Workplace integrate and process for analysis?

  The Syngo Multimodality Workplace is designed to integrate and process imaging data from multiple modalities, including CT (computed tomography), MRI (magnetic resonance imaging), and X-ray scans. This integration allows radiologists and clinicians to perform advanced functions such as image segmentation, cross-modality registration, and 3D visualization to improve diagnostic accuracy and interpretation of complex datasets.

• Is the Syngo Multimodality Workplace a standalone software, or does it require specific hardware or imaging equipment to function?

  The Syngo Multimodality Workplace is supplied as a software solution intended for use on radiology workstations. It does not function independently but requires integration with compatible imaging equipment to process and analyze multimodal imaging data. The software leverages the underlying hardware infrastructure of the workstation, which is reusable, while the software itself is intended for single-use per clinical session.

• How is the Syngo Multimodality Workplace classified under regulatory standards, and what does this mean for its use in clinical settings?

  The Syngo Multimodality Workplace is classified under FDA Product Code LLZ, which aligns it with specialized radiological image processing and PACS-adjacent tools. It holds FDA 510(k) clearance (K052775) and is categorized as a Class II device under Special Controls for radiological image processing systems. This classification means it has undergone regulatory review to ensure safety and effectiveness for its intended use in enhancing and quantifying medical images for diagnostic purposes.

• Does the Syngo Multimodality Workplace require sterilization, and can it be reused across multiple patients?

  The Syngo Multimodality Workplace does not require sterilization as it is a software-based solution designed for use on radiology workstations. While the software itself is intended for single-use per session, the reusable aspect lies in the underlying hardware infrastructure of the workstation, not the software. This means the hardware can be used repeatedly across multiple patients, but the software session is typically dedicated to a single diagnostic workflow.