SYNGO TrueD
by Siemens Medical Solutions USA, Inc. 2 variants
510(k) K091373
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK091373 | Date20 May 2009 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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 TrueD is a medical diagnostic application designed for the viewing, manipulation, and 3D visualization of medical images. It enables clinicians to compare imaging data from multiple modalities—such as CT, MRI, or PET—and across different time points, facilitating precise diagnostic assessments and treatment planning. The software integrates functional imaging data to enhance diagnostic accuracy and support comprehensive patient evaluations.
SYNGO TrueD is supplied as a software application for use on compatible imaging systems and does not require sterilization or single-use compliance. It operates within radiology workflows, supporting diagnostic imaging workflows in clinical settings. The device holds FDA 510(k) clearance under the product code LLZ, with a traditional review pathway and advisory committee review by the Radiology Panel. No specific MRI safety or sterility classifications are stated in the regulatory data.
Other devices from Siemens Medical Solutions USA, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is SYNGO TrueD used for in clinical settings?
SYNGO TrueD is a diagnostic application designed to help clinicians analyze and compare medical images from multiple modalities—such as CT, MRI, or PET—across different time points. This capability enhances diagnostic accuracy by integrating functional imaging data, supporting comprehensive patient evaluations and treatment planning in radiology workflows.
How is SYNGO TrueD supplied and does it require sterilization?
SYNGO TrueD is supplied as a software application for use on compatible imaging systems. Unlike physical medical devices, it does not require sterilization or single-use compliance, as it operates digitally within radiology workflows.
Is SYNGO TrueD single-use or reusable?
SYNGO TrueD is a software application intended for repeated use within clinical settings. It is not a consumable or single-use device, and its functionality is maintained through updates and compatibility with existing imaging systems.
What regulatory pathway was followed for SYNGO TrueD’s clearance?
SYNGO TrueD received FDA 510(k) clearance under product code LLZ through a traditional review pathway, which includes advisory committee review by the Radiology Panel. The device was deemed substantially equivalent to a predicate product, ensuring compliance with regulatory standards.
Does SYNGO TrueD have any specific MRI safety classifications?
The provided regulatory data does not specify any particular MRI safety classifications for SYNGO TrueD. As a software application, its safety is primarily tied to its integration with compatible imaging systems and adherence to radiology workflow protocols.