# K191544: Synapse 3D Blood Flow Analysis

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Corporation
- Decided: Oct 18, 2019 after 129 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 K010938 (2001). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162376: CAAS MR 4D Flow, Pie Medical Imaging BV (2016) Summary page 4.

## Indications for use
Synapse 3D Blood Flow Analysis is medical imaging software used with Synapse 3D Base Tools that is intended to provide trained medical professionals, with tools to aid them in reading, interpreting, reporting, and treatment planning. Addition to the tools in Synapse 3D Base Tools, Synapse 3D Blood Flow Analysis provides the imaging and assessment tools of blood flow velocity and directions based on multi-slice, multi-phase and velocity encoded MR images.

Source page: https://510kreport.com/device/K191544
Methodology: https://510kreport.com/methodology