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Synapse 3D Optional Tools

by Fujifilm Corporation

510(k) K181773

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 NumberK181773 Date25 Sep 2018ClearedStatusActive

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  • Withdrawn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, 25 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 3D Optional Tools is a Class II X-ray system used in radiology. It is a software-based system for advanced processing and analysis of medical imaging, providing tools for radiological, cardiological, clinical, and surgical workflows.

The device received FDA 510(k) clearance under K-number K181773 on September 25, 2018, and is substantially equivalent to a predicate device. It is manufactured by Fujifilm Corporation and supplied as a software system for use in medical imaging environments.

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