# K111861: Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco Engine

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Systems USA
- Decided: Jan 6, 2012 after 190 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: 10 generations back to K913770 (1991). 170 ancestors in all.
No later device cites it as a predicate yet.
1 of 171 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082427: Syngo MR B17, Siemens Medical Solutions USA, Inc. (2008) Summary page 3.
- K092519: Syngo.X, Siemens AG Medical Solutions (2009) Summary page 3.
- K093621: Syngo.Pet&CT Oncology, Siemens Medical Solutions USA, Inc. (2010) Summary page 3.
- K101119: Syngo Dosimetrist Workspace V2.7 Model: 1056864, Siemens Medical Solutions USA, Inc. (2010) Summary page 3.

## Indications for use
syngo.MR Oncology is a syngovia-based image viewing, processing and reading software. This software allows for oncological MR image evaluation in a structured way. It is a reading application primarily for convenient reading of MR scans of single or multiple body regions up to the entire body which have been acquired for clinical purposes such as oncological screening, staging and grading. The reading application does not block the display of data from other modalities that syngovia supports. syngo.MR 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.MR 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.MR Oncology is a tool to support the standard practices and visual comparisons. The system is not intended for the displaying of digital mammography images for diagnosis in the U.S.

Source page: https://510kreport.com/device/K111861
Methodology: https://510kreport.com/methodology