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Fuji Synapse Workstation Software

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

510(k) K051553

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 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 NumberK051553 Date7 Jul 2005ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0622-06 FDA Unclassified (pre-2012) initiated 3 Feb 2006

    Image orientation and orientation markers may not match when an image is rotated or flipped when the CT Image is preset.

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  • Withdrawn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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