# K160108: Synapse PACS

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical Systems U.S.A, Inc.
- Decided: Feb 3, 2016 after 15 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K913770 (1991). 111 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 120 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112439: Synapse Workstation Software Version 3.3.0, Fujifilm Medical System U.S.A., Inc. (2011) Summary page 4.
- K113244: Synapse MPR Fusion, Fujifilm Medical System U.S.A., Inc. (2011) Summary page 4.

## Most influential descendants
- K190232: Synapse PACS (2019), 3 descendants of its own
- K243647: Synapse PACS (7.5) (2025), 1 descendant of its own
- K173475: Merge PACS (2017), 1 descendant of its own
- K261713: Synapse PACS (7.6.0) (2026), 0 descendants of its own
- K192508: Medsynapse Ris Pacs & Medsynapse VNA (2019), 0 descendants of its own

## Recalls of this device
- Feb 11, 2025 · Class II · Z-1407-2025: The incorrect computed patient age is showing in VX for patients less than 3 months old.
- Mar 2, 2021 · Class II · Z-1348-2021: The wrong patient information may be displayed in the viewer or PowerJacket.
- Sep 11, 2020 · Class II · Z-0878-2021: There is a potential for the wrong patient information may be displayed in the viewer or PowerJacket. Additionally, the incorrect max standard uptake values (SUV) for PET ad CT studies may be returned
- May 22, 2020 · Class II · Z-2471-2020: Lateromedial (LM) and Lateromedial Oblique (LMO) Orientation Markers may be displayed incorrectly on the 3D TOMO slider bar. In addition, the slice location of the image and/or the slice direction cou

## Indications for use
FUJIFILM Synapse PACS Software (client) is intended for use, as a web based application, on an off-the-shelf PC meeting or exceeding minimum specifications and networked with FUJIFILM Synapse PACS Software (Server). The FUJIFILM Synapse PACS Software is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. The Synapse PACS Software can process medical images from the following modality types: plane X-ray radiography, X-ray computed tomography, magnetic resonance imaging, ultrasound, nuclear medicine and images from other DICOM compliant modalities. The FUJIFILM Synapse PACS Software enables the display, comparison and fusion of 3D (MIP/MPR) of CT, MR, PET and SPECT studies. Typical users are radiologists, technologists and clinicians. These functions (MIP/MPR/Fusion) are not intended for Mammography use. The FUJIFILM Synapse PACS Software may be used to process FUJIFILM’s DICOM MG “For Processing” images and also for the display, manipulation, and interpretation of lossless compressed or non-compressed mammography images that have been received in the DICOM For Presentation format and displayed on FDA cleared, DICOM compatible displays for mammography.

Source page: https://510kreport.com/device/K160108
Methodology: https://510kreport.com/methodology