# K183248: Synapse Enterprise Viewer Version 1.0

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Corporation
- Decided: Apr 25, 2019 after 155 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 K954874 (1996). 53 ancestors in all.
No later device cites it as a predicate yet.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161130: ResolutionMD, Calgary Scientific, Inc. (2016) Summary page 4.

## Indications for use
Synapse Enterprise Viewer (EV) is a software-based enterprise image viewer used with general purpose servers and dedicated reading workstations. It allows for communication, reformatting, rendering on the server component and communication and display of DICOM and non-DICOM images as well as reports. The device is intended for use as a diagnostic, review and analysis tool by trained professionals such as radiologists, physicians and technologist. Synapse EV is not intended for diagnostic use on mobile devices. Synapse Enterprise Viewer is not to be used for primary mammography diagnosis.

Source page: https://510kreport.com/device/K183248
Methodology: https://510kreport.com/methodology