# K093621: Syngo.Pet&CT Oncology

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Feb 23, 2010 after 92 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: 9 generations back to K913770 (1991). 134 ancestors in all.
54 later devices descend from it; 8 cite it directly.
0 of 189 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092519: Syngo.X, Siemens AG Medical Solutions (2009) Summary page 2.
- K091373: Syngo Trued, Siemens Medical Solutions USA, Inc. (2009) Summary page 2.
- K073003: Syngo Dual Energy with Extended Functionally, Siemens Medi Cal Solutions, Inc. (2008) Summary page 2.
- K071310: Syngo CT Oncology Software Package, Siemens AG (2007)

## Most influential descendants
- K113029: Syngo Via MI Workflows (2011), 20 descendants of its own
- K123577: Syngo.Via MI Workflows (2013), 19 descendants of its own
- K133644: Syngo.Via MI Workflows (2014), 18 descendants of its own
- K151192: syngo.via MI Workflows (2015), 14 descendants of its own
- K160426: syngo.via MI Workflows (2016), 12 descendants of its own

## Indications for use
syngo.PET&CT Oncology 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. syngo.PET&CT Oncology enables visualization of information that would otherwise have to be visually compared disjointedly. syngo.PET&CT Oncology provides analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations. syngo.PET&CT Oncology is designed to support the oncological workflow including interpretation and evaluation of examinations, and follow up documentation of findings. 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.PET&CT Oncology is a complement to these standard procedures.

Source page: https://510kreport.com/device/K093621
Methodology: https://510kreport.com/methodology