Syngo Multimodality Workplace
by Siemens AG Medical Solutions 510(k)
Active
510(k) K061964
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK061964 | Date27 Jul 2006 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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, 6 Oct 2026
The SYNGO MULTIMODALITY WORKPLACE is a medical diagnostic workstation for viewing, manipulation, communication, and storage of medical images and data on exchange. It is classified as a System, Image Processing, Radiological device within the LLZ classification.
This device is supplied by Siemens AG Medical Solutions and is a Class II device with Special Controls. It is intended for use in radiology settings and has received FDA 510(k) clearance with the K number K061964.
Other devices from Siemens Medi Cal Solutions, Inc.
Questions
AI-generated answers, 6 Oct 2026
What is the SYNGO MULTIMODALITY WORKPLACE used for?
The SYNGO MULTIMODALITY WORKPLACE is a medical diagnostic workstation designed for viewing, manipulation, communication, and storage of medical images and data in radiology settings. It helps healthcare professionals efficiently manage and analyze diagnostic imaging information.
How is the SYNGO MULTIMODALITY WORKPLACE supplied?
The device is supplied by Siemens AG Medical Solutions, a global medical technology company. It is classified as a Class II device with Special Controls, indicating it requires additional regulatory controls beyond general Class II devices to ensure safety and effectiveness.
What regulatory approvals does the SYNGO MULTIMODALITY WORKPLACE have?
The SYNGO MULTIMODALITY WORKPLACE has received FDA 510(k) clearance with the K number K061964. This clearance indicates that the device is substantially equivalent to legally marketed predicate devices and can be marketed in the United States for its intended use in radiology settings.
What is the classification of the SYNGO MULTIMODALITY WORKPLACE?
The device is classified as a System, Image Processing, Radiological device within the LLZ classification. This classification reflects its primary function as an image processing system specifically designed for radiological applications, distinguishing it from other types of medical imaging systems.