# K261713: Synapse PACS (7.6.0)

- Pathway: 510(k) (Special)
- Applicant: FUJIFILM Healthcare Americas Corporation
- Decided: Jun 18, 2026 after 27 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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: 14 generations back to K913770 (1991). 138 ancestors in all.
No later device cites it as a predicate yet.
0 of 139 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243647: Synapse PACS (7.5), FUJIFILM Healthcare Americas Corporation (2025) Summary page 5.

## Indications for use
FUJIFILM Synapse PACS Software is intended for use as a web-based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server. The FUJIFILM Synapse PACS Software can process medical images from DICOM compliant modalities and non-DICOM sources. FUJIFILM Synapse PACS Software provides toolsets for: * Performing measurements on DICOM images * Regional segmentation * Importing and presenting data from modalities (DICOM and non-DICOM), * Solving clinical calculations * Creating and distributing structured reports 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. It enables the display, comparison, fusion, and volume rendering of studies to aid in reading, interpreting, reporting, and treatment planning. Typical users are radiologists, cardiologists, technologists, sonographers, technicians, nurses, and clinicians. MIP, MPR Fusion, and volume rendering are not intended for mammography use. FUJIFILM Synapse PACS Software can 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/K261713
Methodology: https://510kreport.com/methodology