FUJIFILM Imaging System (Suzhou) Co., Ltd.

FDA Device Registration & Listing · Suzhou Jiangsu, CN · Registration 3008787461

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008787461
FEI Number
3008787461
Entity Name
FUJIFILM Imaging System (Suzhou) Co., Ltd.
City/State/Country
Suzhou Jiangsu, CN
Establishment Address
138 Chang Jiang Road, New District, Suzhou Jiangsu 215011, CN
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
N
Expiration Date (Year)
2026
510(k) Number
K042023
PMA Number
N/A

All Registered Proprietary Names

FCR CARBON XL-2 (CR-IR359) FCR XL-2 (CR-IR359) Fuji IP Cassette Type CC FCR Prima T2 (CR-IR392) FCR PRIMA Tm(CR-IR392) FCR CARBON (CR-IR357) FCR Prima T2(CR-IR392) FCR XC-2 (CR-IR357) FCR Prima T(CR-IR392)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2008-03-11

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
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
3003706548 FUJIFILM MATERIAL MANUFACTURING CO., LTD. Shizuoka Area Fujinomiya Shizuoka, JP

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K070563 Vidar Systems Corp. VIDAR VISION 2000 2007-03-16
K190691 Pixxgen Corporation Pixx2430 Digital Diagnostic X-Ray Receptor Panel 2019-04-04
K150150 Rayence Co., Ltd. 1717SGN / 1717SCN Digital Flat Panel X-ray Detector 2015-03-27
K140771 Philips Medical Systems Dmc GmbH PHILIPS ELEVA WORKSPOT 2014-04-25

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0005-2009 Toshiba American Medical Systems Inc 2
Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems.
Z-0031-2007 AGFA Corp. 2
CR DX-S, Image Intensified Fluoroscopic X-ray system.

Similar Registrations

Registration Number Establishment Name Location
3016256852 KA IMAGING INC. Waterloo Ontario, CA
3011825597 FAIR MEDICAL CO.,LTD Kashiwa Chiba, JP
3038614464 Canon.Inc OHTA-KU Tokyo, JP
9614698 CANON INC. OTAWARA-SHI Tochigi, JP
3003775006 FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office HANAMAKI-SHI Iwate, JP
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008787461. Last updated year: 2026. Please use registration number 3008787461 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.