Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038614464

FEI Number

3038614464

Entity Name

Canon.Inc

City/State/Country

OHTA-KU Tokyo, JP

Establishment Address

30-2, SHIMOMARUKO 3-CHOME,, OHTA-KU Tokyo 146-8501, JP

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

CANON INC. (Owner Number: 8030410)

Owner / Operator Contact Address

30-2 SHIMOMARUKO, 3-CHOME,, OHTA-KU, JP-13 146-8501, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K131106

PMA Number

N/A

All Registered Proprietary Names

DIGITAL RADIOGRAPHY CXDI-710C Wireless, CXDI-810C Wireless CANON DR IMAGE VIEWER CXDI-401G, CXDI-401C, CXDI-401G COMPACT, CXDI-401C COMPACT CSX-30 Flat Panel Detector CXDI-70C Wireless Digital Retinal Camera CR-2 Plus AF Digital Retinal Camera CR-2 AF Digital Retinal Camera CR-2 Plus AF CSX-20 CXDI-55G Ophthalmic Software Platform RX DIGITAL RADIOGRAPHY E1 DIGITAL RADIOGRAPHY CXDI-Elite Full Auto Tonometer TX-20 CF-1 FULL AUTO REF-KERATOMETER RK-F2 AUTOREF LENSMETER RL-10 FULL AUTO REF-KERATOMETER RK-F3m CANON AUTO REF-KERATOMETER RK-3 Optical Coherence Tomography OCT-A1 DIGITAL RADIOGRAPHY CXDI-702C Wireless, CXDI-402C Wireless DYNAMIC/STATIC DR CXDI-50RF DIGITAL RADIOGRAPHY CXDI-Pro DIGITAL RADIOGRAPHY D1 DIGITAL RADIOGRAPHY E1 DIGITAL RADIOGRAPHY CXDI-Elite DIGITAL RETINAL CAMERA CX-1 CXDI-55C DIGITAL RADIOGRAPHY CXDI-401C Wireless DIGITAL RADIOGRAPHY D1 DIGITAL RADIOGRAPHY CXDI-Pro imageSPECTRUM DIGITAL RADIOGRAPHY CXDI-Elite DIGITAL RADIOGRAPHY E1 DIGITAL RADIOGRAPHY CXDI-701C Wireless, CXDI-701G Wireless, CXDI-801C Wireless, CXDI-801G Wireless

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	2017-03-02
LMB	Device, Digital Image Storage, Radiological	Radiology	Class 1	892.2010	2001-05-25
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2011-04-08
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2017-01-30
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2017-01-30
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2010-08-17
HKI	Camera, Ophthalmic, Ac-Powered	Ophthalmic	Class 2	886.1120	2020-07-26
NFJ	System, Image Management, Ophthalmic	Radiology	Class 2	892.2050	2020-07-26
HKI	Camera, Ophthalmic, Ac-Powered	Ophthalmic	Class 2	886.1120	2013-03-26
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2012-06-19
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2009-06-25
NFJ	System, Image Management, Ophthalmic	Radiology	Class 2	892.2050	2018-02-27
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2022-04-14
HKX	Tonometer, Ac-Powered	Ophthalmic	Class 2	886.1930	2011-10-24
HKI	Camera, Ophthalmic, Ac-Powered	Ophthalmic	Class 2	886.1120	2008-02-15
HKO	Refractometer, Ophthalmic	Ophthalmic	Class 1	886.1760	2002-05-09
OBO	Tomography, Optical Coherence	Ophthalmic	Class 2	886.1570	2019-07-24
HLI	Ophthalmoscope, Ac-Powered	Ophthalmic	Class 2	886.1570	2019-07-24
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2019-11-07
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2013-07-17
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2013-07-17
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2013-07-17
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2021-09-27
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2023-01-10
NFJ	System, Image Management, Ophthalmic	Radiology	Class 2	892.2050	2010-03-25
HKI	Camera, Ophthalmic, Ac-Powered	Ophthalmic	Class 2	886.1120	2010-03-25
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2009-06-25
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2014-07-03
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2022-04-14
NFJ	System, Image Management, Ophthalmic	Radiology	Class 2	892.2050	2020-10-13
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2022-09-15
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2013-07-10

Official Correspondent

No official correspondent registered.

US Agent Details

John CORWIN Business: Canon Medical Components U.S.A., Inc. Email: jcorwin@mcu.canon Phone: (949) 2412582

Related Public Records

Same Entity

CANON INC.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004026651	CANON COMPONENTS, INC.	KODAMA-GUN Saitama, JP
1000181430	CANON INC.	Kawasaki Kanagawa, JP
9614698	CANON INC.	OTAWARA-SHI Tochigi, 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
K863853	Superior Medical Products	EAZY COVERS	1987-03-06

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.
Z-0001-2007	GE OEC Medical Systems, Inc	2	GE 4 inch Anterior Cervical Post, GE Part Number 1006385 or 1006385-NAV, GE Healthcare OEC Medical Systems (an accessory used with the InstaTrak 3500 plus and 9800 C-Arm Navigation systems)
Z-0001-2009	Philips Medical Systems North America Co. Phillips	2	NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System (software). Whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is an interactive program used for x-ray scan control, image reconstruction, and image archive/evaluation. It is intended to produce cross-section images of head and body by computer reconstruction of x-ray transmission data taken at different angles. The function of Time Scan is intended to use in contrast scan include single phase and multi-phase scan, that is according to different density of contrast in vessels or organs between different phase to get necessary information to support doctor's diagnosis.
Z-0004-2010	Ge Healthcare	2	GE OEC 9900 Elite ESP To produce mobile fluoroscopic images of human anatomy.

Similar Registrations

Registration Number	Establishment Name	Location
3016256852	KA IMAGING INC.	Waterloo Ontario, CA
3011825597	FAIR MEDICAL CO.,LTD	Kashiwa Chiba, JP
9614698	CANON INC.	OTAWARA-SHI Tochigi, JP
3003775006	FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office	HANAMAKI-SHI Iwate, JP
1000181430	CANON INC.	Kawasaki Kanagawa, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038614464. Last updated year: 2026. Please use registration number 3038614464 when referencing this establishment in official correspondence.