# K120637: Synapse 3D Brain Perfusion

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical System U.S.A., Inc.
- Decided: May 8, 2012 after 68 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: 11 generations back to K911667 (1991). 40 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103687: Synapse 3D Cerebral Analysis, Fujifilm Medical System U.S.A., Inc. (2011) Summary page 2.
- K080762: IB Neuro, Version 1.0, Imaging Biometrics, LLC (2008) Summary page 2.

## Most influential descendants
- K162287: Synapse 3D Perfusion Analysis (2017), 0 descendants of its own

## Indications for use
Synapse 3D Brain Perfusion 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 Brain Perfusion accepts DICOM conmpliant 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 Brain Perfusion provides the parameter images by post-processing with dynamic scanned CT cerebral arteriography images and magnetic resonance images (MR) with contrast agent to aid the assessment of cerebral blood flow. The parameter images are Cerebral Blood Volume (CBV), Cerebral Bbood Flow (CBF), Mean Transit Time (MUT), and Time To Peak (UTP).

Source page: https://510kreport.com/device/K120637
Methodology: https://510kreport.com/methodology