# K051553: Fuji Synapse Workstation Software

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical Systems U.S.A, Inc.
- Decided: Jul 7, 2005 after 24 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
19 later devices descend from it; 6 cite it directly.
0 of 20 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 its predicate without a number.
- (no number) CR Console (Flash IIP): named in the summary without a submission number
- (no number) Light Beam Workstation: named in the summary without a submission number
- (no number) Arnicas, Inc.: named in the summary without a submission number
- (no number) IDS5/mx.net Workstation: named in the summary without a submission number

## Most influential descendants
- K112439: Synapse Workstation Software Version 3.3.0 (2011), 11 descendants of its own
- K160108: Synapse PACS (2016), 8 descendants of its own
- K190232: Synapse PACS (2019), 3 descendants of its own
- K090649: Vrad Picture Archiving and Communications System Software (2009), 2 descendants of its own
- K243647: Synapse PACS (7.5) (2025), 1 descendant of its own

## Recalls of this device
- Feb 3, 2006 · Not classified · Z-0622-06: Image orientation and orientation markers may not match when an image is rotated or flipped when the CT Image is preset.

## Indications for use
Fuji 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 Fuji 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 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 tleared, DICOM compatible, displays. Synapse does not provide spatial frequency enhancement, dynamic range control, or mulli-objective frequency image processing for DICOM MG “For Presentation” mammography images.

Source page: https://510kreport.com/device/K051553
Methodology: https://510kreport.com/methodology