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syngo.plaza

FDA 510(k)

Class II (US FDA 510(k))

510(k) K180563

by Siemens Healthcare GmbH

Identifiers

510(k) Number
K180563 FDA 510(k)
FDA Product Code
LLZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.2050 FDA 510(k)
Regulation Number
892.2050 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

syngo.plaza is a Picture Archiving and Communication System (PACS) designed for the storage, retrieval, and display of medical imaging studies. It integrates 2D, 3D, and 4D imaging data into a unified platform, enabling radiologists and clinicians to efficiently analyze and interpret diagnostic images across multiple modalities.

syngo.plaza is supplied as a software solution for IT and clinical administrators, supporting fast and efficient reading workflows in radiology departments. It is intended for use in clinical settings and is not classified as single-use or reusable hardware. The system is regulated under FDA 510(k) clearance (K180563) and is manufactured by Siemens Healthcare GmbH, Erlangen, Germany.

Frequently asked questions

What is the primary purpose of syngo.plaza in a clinical setting and how does it improve workflow efficiency for radiologists?

syngo.plaza is a Picture Archiving and Communication System (PACS) designed to streamline the storage, retrieval, and display of medical imaging studies—including 2D, 3D, and 4D data—across multiple modalities. It integrates imaging data into a unified platform, allowing radiologists and clinicians to analyze and interpret diagnostic images more efficiently. By centralizing workflows, it reduces time spent searching for studies and enhances collaboration, ultimately improving diagnostic accuracy and department productivity.

Is syngo.plaza a physical device or a software solution, and how is it typically deployed in a hospital?

syngo.plaza is not a physical hardware device but a software-based PACS solution intended for IT and clinical administrators. It is deployed within radiology departments to integrate with existing imaging systems, enabling seamless storage, retrieval, and display of medical images. The software is installed on hospital servers or networks, requiring IT infrastructure to support its operation.

How is syngo.plaza regulated, and what does the FDA’s 510(k) clearance (K180563) indicate about its safety and effectiveness?

syngo.plaza has received FDA 510(k) clearance under K180563, which means it has been determined to be substantially equivalent to a legally marketed predicate device in terms of technology and safety. This clearance indicates that the FDA has reviewed its design, performance, and risk management to ensure it meets regulatory standards for medical imaging software. However, the clearance does not imply approval for specific clinical indications—only that it complies with FDA requirements for PACS systems.

Who is the manufacturer responsible for syngo.plaza, and where can additional information or support be obtained?

syngo.plaza is manufactured by Siemens Healthcare GmbH, headquartered in Erlangen, Germany. For technical inquiries, support, or further details, contact can be directed to Vijay Ramadas at the provided address: Henkestrasse 127, 91502 Erlangen, Germany. Siemens Healthcare also likely offers dedicated customer support channels for hospitals implementing the system.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: syngo.plaza - Siemens Healthineers Suisse, syngo.plaza - Siemens Healthineers USA, syngo.plaza (PACS) | Siemens Healthineers Academy, Siemens Healthineers Syngo.plaza - healthcare.toolsinfo.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Siemens Healthcare GmbH

Sources (1)

  • FDA 510(k) K180563 24 fields · synced Oct 6, 2026