Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005930550

FEI Number

3005930550

Entity Name

FUJIFILM Corporation Medical Systems Research & Development Center Minamiaoyama

City/State/Country

Minato Tokyo, JP

Establishment Address

6 Chome 6-15, Minamiaoyama, Minato Tokyo 107-0062, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

FUJIFILM CORPORATION (Owner Number: 8031568)

Owner / Operator Contact Address

26-30, Nishiazabu 2-chome, MINATO-KU, JP-13 106-8620, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K123566

PMA Number

N/A

All Registered Proprietary Names

Synapse 3D Base Tools V6.6 Synapse 3D Base Tools V7 Synapse 3D Cardiac Tools Synapse 3D Optional Tools Endoscope Simulator Synapse 3D Lung and Abdomen Analysis Lung Analysis Resection Synapse 3D Perfusion Analysis Synapse 3D Blood Flow Analysis Synapse 3D Liver and Kidney Analysis Liver Analysis Kidney Analysis Synapse 3D Base Tools (V7.2) Synapse 3D Colon Analysis

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2022-11-23
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2025-05-22
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2025-05-22
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2020-08-27
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2018-11-26
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2016-04-06
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2018-01-12
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2018-01-12
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2019-11-13
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2016-04-06
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2026-05-08
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2026-05-08
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2013-01-31

Official Correspondent

No official correspondent registered.

US Agent Details

Randy Vader Business: FUJIFILM Healthcare Americas Corporation Email: randy.vader@fujifilm.com Phone: (360) 3566821

Related Public Records

Same Entity

FUJIFILM CORPORATION

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3020707080	FUJIFILM medwork GmbH	Hochstadt/Aisch Bavaria, DE
3008787461	FUJIFILM Imaging System (Suzhou) Co., Ltd.	Suzhou Jiangsu, CN
2155	FUJIFILM Healthcare Manufacturing Corporation Minamiashigara Takematsu Office	MINAMIASHIGARA-SHI Kanagawa, JP
3005625991	FUJIFILM Healthcare Americas Corporation	Edison, NJ, US
3034364687	FUJIFILM Corporation Material Manufacturing Headquarters	Fujinomiya Shizuoka, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17
K042221	Barco NV Barcoview	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	2004-12-30
K092915	Cedara Software Corp.	CEDARA WEBACCESS, MODEL: 2.4	2010-06-23
K961871	Siemens Medical Solutions USA, Inc.	FLOUROSPOT T.O.P.	1996-07-31
K122260	Aycan Digitalsysteme GmbH	AYCAN MOBILE	2012-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026	CHANGE HEALTHCARE CANADA COMPANY	2	Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012	Philips Healthcare Inc.	2	MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007	AGFA Corp.	2	IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005930550. Last updated year: 2026. Please use registration number 3005930550 when referencing this establishment in official correspondence.