# K162287: Synapse 3D Perfusion Analysis

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical Systems U.S.A, Inc.
- Decided: Apr 6, 2017 after 234 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: 12 generations back to K911667 (1991). 70 ancestors in all.
No later device cites it as a predicate yet.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120637: Synapse 3D Brain Perfusion, Fujifilm Medical System U.S.A., Inc. (2012) Summary page 4.
- K150713: syngo.CT Myocardial Perfusion, Siemens Medical Solutions USA, Inc. (2015) Summary page 4.
- K092013: Syngo Volume Perfusion-CT Body, Siemens AG Medical Solutions (2009) Summary page 4.

## Indications for use
Synapse 3D Perfusion 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. Synapse 3D Perfusion Analysis accepts DICOM compliant medical images acquired from CT and MR. This product is not intended for use with or for the primary diagnostic interpretation of Mammography images. Addition to Synapse 3D Base Tools, Synapse 3D Perfusion Analysis provides the parameter images by post-processing of dynamic scanned CT arteriography and magnetic resonance (MR) images acquired with contrast agents to aid the assessment of cerebral (CT and MR), myocardial (CT) and abdomen (CT) blood flows. The parameter images are Blood Volume (BV), Blood Flow (BF), Mean Transit Time (MTT), and Time To Peak (TTP).

Source page: https://510kreport.com/device/K162287
Methodology: https://510kreport.com/methodology