# K112439: Synapse Workstation Software Version 3.3.0

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical System U.S.A., Inc.
- Decided: Oct 17, 2011 after 54 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K051553 (2005). 2 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051553: Fuji Synapse Workstation Software, Fujifilm Medical Systems U.S.A, Inc. (2005) Summary page 1.
- P050014: Fuji's Computed Radiography  Mammography Suite (Fcrms), Fujifilm Medical System U.S.A., Inc. (2006) Summary page 1.

## Most influential descendants
- K160108: Synapse PACS (2016), 8 descendants of its own
- 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
- K162145: vRad PACS with Mammography (2016), 1 descendant of its own

## Recalls of this device
- Sep 15, 2016 · Class II · Z-0073-2017: Image data for a patients image may not be correct
- May 10, 2016 · Class II · Z-2043-2016: Synapse cannot display image files, DICOM SR files, and/or Annotation files. The "Image Not Loaded" message displays instead

## Indications for use
FUJIFILM Synapse Workstation Software is intended for installation on an off-the-shelf PC meeting or exceeding minimum specifications and networked with Fuji Synapse PACS. The FUJIFILM Synapse Workstation 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 Workstation 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 Synapse Workstation may be used to process 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/K112439
Methodology: https://510kreport.com/methodology