Data / Medical devices / Japan / Canon.Inc
Canon.Inc: FDA-registered device maker in OHTA-KU Tokyo, Japan, 30 510(k) clearances
Canon.Inc is registered with the FDA (registration 3038614464) in OHTA-KU Tokyo, Japan. It lists 11 device types. The FDA files 30 510(k) clearances under its listings, the newest dated May 15, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3038614464
- Address
- 30-2, Shimomaruko 3-Chome, OHTA-KU Tokyo, Japan, 146-8501
- Owner or operator
- CANON INC. (8030410)
- Roles
- Specification developer
- First device listed
- May 25, 2001
- Registered through
- 2026
- Brand names listed
- AUTOREF LENSMETER RL-10, CANON AUTO REF-KERATOMETER RK-3, CANON DR IMAGE VIEWER, CF-1, CSX-20, CSX-30 Flat Panel Detector, CXDI-401G, CXDI-401C, CXDI-401G COMPACT, CXDI-401C COMPACT, CXDI-40G COMPACT and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Camera, Ophthalmic, Ac-Powered | HKI | 2 | Specification developer | accessdata.fda.gov |
| Device, Digital Image Storage, Radiological | LMB | 1 | Specification developer | accessdata.fda.gov |
| Interventional Fluoroscopic X-Ray System | OWB | 2 | Specification developer | accessdata.fda.gov |
| Ophthalmoscope, Ac-Powered | HLI | 2 | Specification developer | accessdata.fda.gov |
| Refractometer, Ophthalmic | HKO | 1 | Specification developer | accessdata.fda.gov |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | 2 | Specification developer | accessdata.fda.gov |
| System, Image Management, Ophthalmic | NFJ | 2 | Specification developer | accessdata.fda.gov |
| System, X-Ray, Angiographic | IZI | 2 | Specification developer | accessdata.fda.gov |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | 2 | Specification developer | accessdata.fda.gov |
| Tomography, Optical Coherence | OBO | 2 | Specification developer | accessdata.fda.gov |
| Tonometer, Ac-Powered | HKX | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 15, 2024 | K241049 | CANON Fundus Camera CR-10 (CR-10) | HKI | Substantially Equivalent | Canon, Inc. | accessdata.fda.gov |
| October 17, 2022 | K222855 | Digital Radiography CXDI-Pro, Digital Radiography D1 | MQB | Substantially Equivalent | Canon, Inc. | accessdata.fda.gov |
| September 29, 2022 | K222687 | Digital Radiography CXDI-Elite, Digital Radiography E1 | MQB | Substantially Equivalent | Canon, Inc. | accessdata.fda.gov |
| July 15, 2022 | K221876 | Digital Radiography CXDI-Pro, Digital Radiography D1 | MQB | Substantially Equivalent | Canon, Inc. | accessdata.fda.gov |
| June 14, 2022 | K221620 | Digital Radiography CXDI-Elite, Digital Radiography E1 | MQB | Substantially Equivalent | Canon, Inc. | accessdata.fda.gov |
| February 4, 2022 | K220098 | Digital Radiography CXDI-Pro, Digital Radiography D1 | MQB | Substantially Equivalent | Canon, Inc. | accessdata.fda.gov |
| January 24, 2022 | K213780 | DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1 | MQB | Substantially Equivalent | Canon, Inc. | accessdata.fda.gov |
| September 9, 2021 | K212553 | DIGITAL RADIOGRAPHY CXDI-Pro, D1 | MQB | Substantially Equivalent | Canon, Inc. | accessdata.fda.gov |
| September 25, 2020 | K201273 | ImageSPECTRUM | NFJ | Substantially Equivalent | Canon, Inc. | accessdata.fda.gov |
| July 23, 2020 | K201122 | Canon non-mydriatic retinal camera CR series | HKI | Substantially Equivalent | Canon, Inc. | accessdata.fda.gov |
| November 7, 2019 | K192632 | DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C Wireless | MQB | Substantially Equivalent | Canon, Inc. | accessdata.fda.gov |
| July 24, 2019 | K182942 | Canon OCT-A1 | OBO | Substantially Equivalent | Canon, Inc. | accessdata.fda.gov |
| February 23, 2018 | K173689 | Ophthalmic Software Platform RX | NFJ | Substantially Equivalent | Canon Inc. -Medical Equipment Group | accessdata.fda.gov |
| November 17, 2017 | K171270 | DIGITAL RADIOGRAPHY CXDI-410C WIRELESS | MQB | Substantially Equivalent | Canon, Inc. | accessdata.fda.gov |
| March 1, 2017 | K170332 | DIGITAL RADIOGRAPHY CXDI-710C WIRELESS, DIGITAL RADIOGRAPHY CXDI-810C WIRELESS | MQB | Substantially Equivalent | Canon, Inc. | accessdata.fda.gov |
| January 27, 2017 | K162909 | CSX-30 Flat Panel Detector | MQB | Substantially Equivalent | Canon, Inc. Medical Equipment Group | accessdata.fda.gov |
| July 1, 2014 | K133693 | DIGITAL RADIOGRAPHY CXDI-401C WIRELESS | MQB | Substantially Equivalent | Canon, Inc. | accessdata.fda.gov |
| July 3, 2013 | K131106 | DIGITAL RADIOGRAPHY CXDI-701C WIRELESS, DIGITAL RADIOGRAPHY CXDI-70IG WIRELESS, DIGITAL RADIOGRAPHY CXDI-801C WIRELESS, | MQB | Substantially Equivalent | Canon, Inc. | accessdata.fda.gov |
| March 19, 2013 | K123208 | DIGITAL RETINAL CAMERA | HKI | Substantially Equivalent | Canon Inc. -Medical Equipment Group | accessdata.fda.gov |
| June 7, 2012 | K121444 | FLAT PANEL DETECTOR | OWB | Substantially Equivalent | Canon, Inc. - Medical Equpment Group | accessdata.fda.gov |
| September 20, 2011 | K111710 | FULL AUTO TONOMETER MODEL TX-20 | HKX | Substantially Equivalent | Canon Inc. -Medical Equipment Group | accessdata.fda.gov |
| September 2, 2011 | K111682 | DIGITAL RADIOGRAPHY | MQB | Substantially Equivalent | Canon Inc. -Medical Equipment Group | accessdata.fda.gov |
| March 29, 2011 | K103591 | DIGITAL RADIOGRAPHY | MQB | Substantially Equivalent | Canon Inc. -Medical Equipment Group | accessdata.fda.gov |
| August 17, 2010 | K102012 | DIGITAL RADIOGRAPHY | MQB | Substantially Equivalent | Canon Inc. -Medical Equipment Group | accessdata.fda.gov |
| March 18, 2010 | K092565 | DIGITAL RETINAL CAMERA CX-1 | HKI | Substantially Equivalent | Canon Components, Inc. | accessdata.fda.gov |
| November 30, 2009 | K092439 | CANON DIGITAL FLUOROSCOPY AND RADIOGRAPHY, MODEL CXDI-50RF | OWB | Substantially Equivalent | Virtual Imaging, Inc. | accessdata.fda.gov |
| May 29, 2009 | K091436 | DIGITAL RADIOGRAPHY, MODEL CXDI-55C | MQB | Substantially Equivalent | Canon, Inc. | accessdata.fda.gov |
| May 29, 2009 | K091435 | DIGITAL RADIOGRAPHY MODEL CXDI-55G | MQB | Substantially Equivalent | Canon, Inc. | accessdata.fda.gov |
| March 24, 2009 | K090623 | DIGITAL RADIOGRAPHY CXDI-40G COMPACT | MQB | Substantially Equivalent | Canon USA, Inc. | accessdata.fda.gov |
| January 23, 2007 | K063717 | CF-1 | HKI | Substantially Equivalent | Canon, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Interventional Fluoroscopic X-Ray System
- All makers of Solid State X-Ray Imager (Flat Panel/Digital Imager)
- All makers of Refractometer, Ophthalmic
- All makers of Tonometer, Ac-Powered
- All makers of Device, Digital Image Storage, Radiological
- All makers of System, Image Management, Ophthalmic
Updated May 15, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.