# K091373: Syngo Trued

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: May 20, 2009 after 9 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K913770 (1991). 91 ancestors in all.
200 later devices descend from it; 5 cite it directly.
1 of 292 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071950: Syngo Trued, Siemens Medical Solutions USA, Inc. (2007) Summary page 2.
- K063324: Pet Vcar, GE Healthcare (2007) Summary page 2.
- K071964: Mim 4.1 (Seastar), Mimvista Corp. (2007) Summary page 2.
- K032915: Advantage 4D Option, Ge Medical Systems, LLC (2003) Summary page 2.
- K063762: Syngo Circulation Software Package with Extended Functionality, Siemens AG Medical Solutions (2007) Summary page 2.

## Most influential descendants
- K101749: Syngo Trued Software (2010), 76 descendants of its own
- K101228: Mirada XD (2010), 70 descendants of its own
- K123920: Syngo.Via (2013), 63 descendants of its own
- K093621: Syngo.Pet&CT Oncology (2010), 54 descendants of its own
- K150843: syngo®.via (version VB10A) (2015), 46 descendants of its own

## Indications for use
syngo TrueD is a medical diagnostic application for viewing, manipulation, 3D- visualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR. The images can be viewed in a number of output formats including MIP and volume rendering. syngo TrueD enables visualization of information that would otherwise have to be visually compared disjointedly. syngo TrueD provides analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations. syngo TrueD is designed to support the oncological.workflow by helping the user to confirm the absence or presence of lesions, including evaluation, quantification, follow-up and documentation of any such lesions. The application allows to store and export volume of interest (VOl) structures in DICOM RT format for use in radiation therapy planning systems. syngo TrueD a/lows visualization and analysis of respiratory gated studies to support accurate delineation of the target or treatmentvolume over a defined phase of the respiratory cycle and thus provide information for radiationtherapy planning. Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. syngo TrueD is a complement to these standard procedures.

Source page: https://510kreport.com/device/K091373
Methodology: https://510kreport.com/methodology