# K190232: Synapse PACS

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Corporation
- Decided: Mar 26, 2019 after 48 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K913770 (1991). 113 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 117 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160108: Synapse PACS, Fujifilm Medical Systems U.S.A, Inc. (2016) Summary page 4.
- K151859: Synapse Cardiovascular, Fujifilm Medical Systems U.S.A, Inc. (2015) Summary page 4.

## Most influential descendants
- K243647: Synapse PACS (7.5) (2025), 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
- Jul 22, 2026 · Class II · Z-3030-2026: Software issue may cause the ruler measurement to be inaccurate.
- Feb 11, 2025 · Class II · Z-1407-2025: The incorrect computed patient age is showing in VX for patients less than 3 months old.
- Jan 10, 2024 · Class II · Z-1272-2024: Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.
- Jan 10, 2024 · Class II · Z-1271-2024: Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.
- Jan 10, 2024 · Class II · Z-1268-2024: Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.
- Jan 10, 2024 · Class II · Z-1270-2024: Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.
- Jan 10, 2024 · Class II · Z-1269-2024: Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.
- Jan 10, 2024 · Class II · Z-1273-2024: Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.
- Jan 3, 2024 · Class II · Z-1171-2024: The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the mass of the left ventricle (LV Mass). If used as a main factor for diagnosis, there is a risk of misdiagn
- Dec 11, 2020 · Class II · Z-0918-2021: The software does not update measurements and calculations in the Clinical Reporting Application (CRA) when the ventricular trace is changed in the study by a different user.
- Sep 11, 2020 · Class II · Z-0282-2021: FUJIFILM has become aware of the possibility that certain CT studies may report a much higher 3D Sphere MAX value than expected. This issue is specific to 3D Sphere - other density tools are not affec

## 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. The FUJIFILM Synapse PACS Software provides toolsets for performing measurements on DICOM images, importing and presenting data from modalities (DICOM and non-DICOM), solving clinical calculations, and creating and distributing structured reports. 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. It enables the display, comparison and fusion of 3D (MIP/MPR) of CT, MR, PET and SPECT studies. Typical users are radiologists, cardiologists, technologists, sonographers, technicians, nurses and clinicians. MIP, MPR, and 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/K190232
Methodology: https://510kreport.com/methodology