# K103687: Synapse 3D Cerebral Analysis

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical System U.S.A., Inc.
- Decided: Mar 4, 2011 after 77 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K120637: Synapse 3D Brain Perfusion (2012), 1 descendant of its own
- K162287: Synapse 3D Perfusion Analysis (2017), 0 descendants of its own

## Indications for use
Synapse 3D Cerebral Analysis is medical imaging software used with Synapse 3D Basic Tools that is intended to provide trained medical imaging professionals, including Physicians and Radiologists, with tools to aid them in reading, interpreting, reporting, and treatment planning. Synapse 3D Cerebral Analysis accepts DICOM compliant medical images acquired from CT. This product is not intended for use with or for the primary diagnostic interpretation of Mammography images. Addition to Synapse 3D Basic Tools, Synapse 3D Cerebral Analysis provides the parameter images by post-processing with dynamic scanned CT cerebral arteriography images to aid the assessment of cerebral blood flow. The parameter images are Cerebral Blood Volume (CBV), Cerebral Blood Flow (CBF), Mean Transit Time (MTT), and Time To Peak (UTP).

Source page: https://510kreport.com/device/K103687
Methodology: https://510kreport.com/methodology