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Synapse PACS

by Fujifilm Medical Systems U.S.A, Inc.

510(k) K160108

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

4 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK160108 Date3 Feb 2016ClearedStatusActive

Recalls

4 recalls · 4 ongoing · FDA

    • Ongoing Z-1407-2025 FDA Class II initiated 11 Feb 2025

    The incorrect computed patient age is showing in VX for patients less than 3 months old.

    • Ongoing Z-1348-2021 FDA Class II initiated 2 Mar 2021

    The wrong patient information may be displayed in the viewer or PowerJacket.

    • Ongoing Z-0878-2021 FDA Class II initiated 11 Sep 2020

    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 for Siemens Modality.

    • Ongoing Z-2471-2020 FDA Class II initiated 22 May 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 could be incorrect as well, and result in misdiagnosis

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Synapse PACS is a Picture Archiving and Communication System (PACS) designed to store, retrieve, and display medical imaging data. It integrates radiology, mammography, cardiology, pathology, and specialty department studies into a unified diagnostic viewer, enabling comprehensive access to patient imaging across multiple clinical disciplines.

The system is supplied as a software solution for integration into hospital or clinical IT infrastructure, supporting both on-site and remote clinician access. It is intended for use in radiology departments and other clinical settings where multi-modality imaging review is required. The device has received FDA clearance under 510(k) number K160108, classified under product code LLZ and reviewed by the Radiology Advisory Committee.

Other devices from Fujifilm Medical System U.S.A., Inc.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical specialties does the Synapse PACS support for imaging review?

    The Synapse PACS is designed to consolidate imaging data from radiology, mammography, cardiology, pathology, and specialty departments into a single diagnostic viewer. This integration allows clinicians across multiple disciplines to access and review patient studies in one unified platform, improving diagnostic efficiency and collaboration.

  • How is the Synapse PACS supplied and where can it be installed?

    Synapse PACS is supplied as a software solution intended for integration into existing hospital or clinical IT infrastructure. It supports both on-site deployment and remote clinician access, making it adaptable to various healthcare settings where multi-modality imaging review is required.

  • Is the Synapse PACS intended for single-use or reusable applications?

    As a software-based Picture Archiving and Communication System (PACS), Synapse PACS is not designed for single-use or disposable applications. It is a reusable system that requires integration into an IT environment and is maintained over time for continuous use in clinical settings.

  • What regulatory pathway was followed for the Synapse PACS?

    The Synapse PACS received FDA clearance under the 510(k) pathway, specifically under 510(k) number K160108. The device was classified under product code LLZ and reviewed by the Radiology Advisory Committee, with a decision of substantial equivalence to a predicate device.

  • Can the Synapse PACS be used for remote clinician access?

    Yes, the Synapse PACS supports remote clinician access as part of its design. This feature enables healthcare professionals to review and analyze patient imaging studies from off-site locations, enhancing flexibility and continuity of care in distributed healthcare environments.