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Synapse 3D Liver and Kidney Analysis

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

510(k) K142521

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 NumberK142521 Date1 Dec 2014ClearedStatusActive

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  • Withdrawn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
FDA applicant
Fujifilm Meidcal Systems U.S.A.,Inc.
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Liver and Kidney Analysis is a medical imaging software tool designed for three-dimensional analysis of liver and kidney structures. It processes contrast-enhanced CT and MR images to generate segmented 3D visualisations, enabling detailed anatomical assessment and preoperative planning, including liver segmentation and hepatectomy simulation.

The software is supplied as part of the Synapse 3D Base Tools platform and is intended for use by trained medical imaging professionals, such as radiologists and physicians. It operates on contrast-enhanced imaging data, producing 3D masks for surgical planning and embolization procedures. The device holds FDA 510(k) clearance under the product code LLZ, with a traditional review pathway through the Radiology Advisory Committee.

Other devices from Fujifilm Meidcal Systems U.S.A., Inc.