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Synapse Workstation Software Version 3.3.0

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

510(k) K112439

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

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 NumberK112439 Date17 Oct 2011ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0073-2017 FDA Class II initiated 15 Sep 2016

    Image data for a patients image may not be correct

    • Terminated Z-2043-2016 FDA Class II initiated 10 May 2016

    Synapse cannot display image files, DICOM SR files, and/or Annotation files. The "Image Not Loaded" message displays instead

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  • Withdrawn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

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