CANON COMPONENTS, INC.

FDA Device Registration & Listing · KODAMA-GUN Saitama, JP · Registration 3004026651

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
3004026651
FEI Number
1000582291
Entity Name
CANON COMPONENTS, INC.
City/State/Country
KODAMA-GUN Saitama, JP
Establishment Address
3461-1 SHICHIHONGI, OAZA, KAMISATO-MACHI, KODAMA-GUN Saitama 369-0393, JP
Establishment Type(s)
Manufacture Medical Device
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
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

CXDI-55G Full Auto Tonometer TX-20 DIGITAL RADIOGRAPHY E1 DIGITAL RADIOGRAPHY CXDI-Elite CXDI-55C CXDI-70C Wireless CXDI-501G, CXDI-501C CXDI-40G COMPACT DIGITAL RADIOGRAPHY CXDI-701C Wireless, CXDI-701G Wireless, CXDI-801C Wireless, CXDI-801G Wireless DIGITAL RADIOGRAPHY CXDI-401C Wireless Digital Retinal Camera CR-2 Plus AF DIGITAL RADIOGRAPHY CXDI-Elite DIGITAL RADIOGRAPHY E1 DIGITAL RETINAL CAMERA CX-1 DIGITAL RADIOGRAPHY CXDI-Pro DIGITAL RADIOGRAPHY D1 CXDI-401G, CXDI-401C, CXDI-401G COMPACT, CXDI-401C COMPACT CF-1 Digital Retinal Camera CR-2 Plus AF Digital Retinal Camera CR-2 AF DIGITAL RADIOGRAPHY CXDI-710C Wireless, CXDI-810C Wireless CSX-30 Flat Panel Detector DIGITAL RADIOGRAPHY E1 DIGITAL RADIOGRAPHY CXDI-Elite DIGITAL RADIOGRAPHY CXDI-410C WIRELESS CSX-20 Optical Coherence Tomography OCT-A1 DIGITAL RADIOGRAPHY CXDI-702C Wireless, CXDI-402C Wireless DIGITAL RADIOGRAPHY D1 DIGITAL RADIOGRAPHY CXDI-Pro

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 2009-06-25
HKX Tonometer, Ac-Powered Ophthalmic Class 2 886.1930 2011-10-24
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2022-04-14
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 2010-08-17
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2011-09-09
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2009-04-01
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2013-07-10
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2014-07-03
HKI Camera, Ophthalmic, Ac-Powered Ophthalmic Class 2 886.1120 2013-03-26
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2022-09-15
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 2022-09-15
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2011-04-08
HKI Camera, Ophthalmic, Ac-Powered Ophthalmic Class 2 886.1120 2008-02-15
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
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2017-03-02
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 2023-01-10
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2017-12-07
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2012-06-19
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
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2022-04-14

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
1000181430 CANON INC. Kawasaki Kanagawa, JP
9614698 CANON INC. OTAWARA-SHI Tochigi, JP
3038614464 Canon.Inc OHTA-KU Tokyo, 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
K870750 Keeler Instruments, Inc. KEELER PULSAIR NON CONTACT TONOMETER 1987-03-17

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-0009-2018 Optovue, Inc. 2
iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina and external areas of the eye to be evaluated under non-mydriatic conditions. The iCam takes digital images of the posterior and external structures of the eye without the use of a mydriatic agent and is intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health. iCam provides images only and does not provide any diagnostic, pathological analysis or classification of ocular health or disease. AND iVue with Normative Database (K121739) - The iVue is a noncontact, high resolution optical coherence tomography system intended for in vivo imaging, axial cross-sectional, three-dimensional imaging and measurement of anterior and posterior. ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue with Normative Database is a quantitative tool for comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects.
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004026651. Last updated year: 2026. Please use registration number 3004026651 when referencing this establishment in official correspondence.
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