Syngo US Workplace
by Siemens Medical Solutions 510(k)
Active
510(k) K060992
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK060992 | Date28 Apr 2006 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
-
- Terminated Z-1138-2008
Inaccurate results: A software bug may cause inaccurate wall motion abnormality scoring results to be displayed.
Specification
- 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, 1 Oct 2026
Syngo US Workplace is a radiology information and communication platform designed for off-the-system use. It integrates with DICOM-compliant imaging systems to provide a centralized workspace for viewing, managing, and analyzing medical images from multiple vendors. The software supports advanced clinical applications, enabling radiologists and clinicians to streamline diagnostic workflows and enhance productivity. Its modular design allows for compatibility with a range of imaging modalities, including ultrasound systems.
This software solution is supplied as a standalone application for use in radiology departments, hospitals, or clinical settings where image review and analysis are performed. It is intended for single-user or multi-user environments, though sterility and single-use/reusable status are not applicable as it is a digital platform. The system is MRI-safe as it does not contain magnetic or conductive components that could interfere with MRI environments. Authorized under FDA 510(k) clearance (K060992), it adheres to regulatory standards for medical imaging software and is intended for use in approved healthcare facilities.
Other devices from Siemens Medi Cal Solutions, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Syngo US Workplace designed for?
Syngo US Workplace is a radiology information and communication platform designed for off-the-system use. It integrates with DICOM-compliant imaging systems to provide a centralized workspace for viewing, managing, and analyzing medical images from multiple vendors. This software supports advanced clinical applications, helping radiologists and clinicians streamline diagnostic workflows and enhance productivity in radiology departments, hospitals, or clinical settings.
How is the Syngo US Workplace supplied, and is it single-use or reusable?
The Syngo US Workplace is supplied as a standalone software application, not a physical device. Since it is a digital platform, sterility and single-use/reusable status do not apply. It is intended for use in single-user or multi-user environments, depending on the clinical or administrative setup.
Is the Syngo US Workplace compatible with MRI environments?
Yes, the Syngo US Workplace is designed to be MRI-safe. It does not contain any magnetic or conductive components that could interfere with MRI equipment or environments, making it suitable for use in facilities where MRI systems are present.
What imaging modalities does the Syngo US Workplace support?
The Syngo US Workplace supports a range of imaging modalities, including ultrasound systems, due to its modular design. This flexibility allows it to integrate with various DICOM-compliant imaging systems, enabling comprehensive image review and analysis across different modalities in a centralized workspace.
What regulatory clearance does the Syngo US Workplace hold?
The Syngo US Workplace holds FDA 510(k) clearance under the reference number K060992. This clearance indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device and adheres to regulatory standards for medical imaging software.