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Synapse Enterprise Viewer Version 1.0

by Fujifilm Corporation

510(k) K183248

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 NumberK183248 Date25 Apr 2019ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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, 23 Sep 2026

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

Synapse Enterprise Viewer is a software-based enterprise image viewer used with general purpose servers and dedicated reading workstations. It allows for communication and rendering on the server component and communication and display of DICOM images.

The device is supplied as software and is used for viewing medical images. It has FDA 510(k) clearance with product code LLZ and K-number K183248. The device is not described as single-use or reusable, and no information about sterility, MRI safety, or storage is provided.

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Questions

AI-generated answers, 23 Sep 2026

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

  • What is the Synapse Enterprise Viewer Version 1.0 used for?

    The Synapse Enterprise Viewer Version 1.0 is a software-based enterprise image viewer designed for communication and rendering on server components, as well as for displaying DICOM images on dedicated reading workstations.

  • How is the Synapse Enterprise Viewer Version 1.0 supplied?

    The device is supplied as software, intended for use with general purpose servers and dedicated reading workstations to facilitate medical image viewing and communication.

  • What regulatory clearance does the Synapse Enterprise Viewer Version 1.0 have?

    The Synapse Enterprise Viewer Version 1.0 has FDA 510(k) clearance with product code LLZ and K-number K183248, determined to be substantially equivalent to predicate devices.

  • Is the Synapse Enterprise Viewer Version 1.0 single-use or reusable?

    The device is not described as single-use or reusable in the provided information, as it is a software product rather than a physical medical device.