# K041484: Undecided

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jul 30, 2004 after 56 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: 5 generations back to K913770 (1991). 7 ancestors in all.
222 later devices descend from it; 1 cites it directly.
1 of 230 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010938: Syngo Multimodality Workstation, Siemens Medical Solutions USA, Inc. (2001) Summary page 2.
- K033374: Lungcare CT Software Package with Extended Functionality, Siemens AG Medical Solutions (2003) Summary page 2.
- K010336: Advantage Windows CT/Pet Fusion, Ge Medical Systems, Inc. (2001) Summary page 2.

## Most influential descendants
- K053301: Cedara I-Response Cedara Pet/CT (2006), 221 descendants of its own
- K071950: Syngo Trued (2007), 201 descendants of its own
- K091373: Syngo Trued (2009), 200 descendants of its own
- K101749: Syngo Trued Software (2010), 76 descendants of its own
- K101228: Mirada XD (2010), 70 descendants of its own

## Indications for use
syngo TrueD is a medical diagnostic application for viewing, image manipulation, 3D visualization and comparison of medical images. syngo TrueD is intended for combining datasets from multiple imaging modalities and/or multiple time-points into a single dataset that accurately represents the information from the initial data. The input datasets could be functional 3D volumes (e.g. PET and SPECT) and/or anatomic 3D volumes (e.g. CT and MR). This “fusion” of data may 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 any 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. 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/K041484
Methodology: https://510kreport.com/methodology