# K110494: Syngo MBF

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Apr 6, 2011 after 43 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: 6 generations back to K913770 (1991). 14 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083327: Syngocirculation Dynamicpet, Version 1.0, Siemens Medical Solutions USA, Inc. (2009) Summary page 2.

## Most influential descendants
- K201195: syngo.via MI Workflows, syngo MBF (2020), 5 descendants of its own
- K211459: syngo.via MI WorkFlows, Scenium, syngo MBF (2021), 4 descendants of its own
- K232000: syngo.via MI Workflows; Scenium; syngo MBF (2023), 3 descendants of its own
- K242275: syngo.via MI Workflows; Scenium; syngo MBF (2024), 2 descendants of its own
- K251528: syngo.via MI Workflows; Scenium; syngo MBF (2025), 1 descendant of its own

## Indications for use
Siemens syngo MBF is a software product intended for visualization, assessment and quantification of PET images. The application performs quantitative measurements of tracer uptake over time to aid in the interpretation of myocardial perfusion PET images. The product is intended for use by trained professionals. The Clinician retains the ultimate responsibility for making the pertinent assessment based on their standard practices and visual comparison of the information. Siemens syngo MBF is a software product intended for visualization, assessment and quantification of PET images. The application performs quantitative measurements of tracer uptake over time to aid in the interpretation of myocardial perfusion PET images. The product is intended for use by trained professionals. The Clinician retains the ultimate responsibility for making the pertinent assessment based on their standard practices and visual comparison of the information.

Source page: https://510kreport.com/device/K110494
Methodology: https://510kreport.com/methodology