Company ยท US
Canon USA, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 2026. Name variants (Inc, Corp, punctuation) are merged.
91510(k) clearances (1 in 12 months)
3recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 34 |
| HKI | Camera, Ophthalmic, Ac-Powered | 19 |
| HKO | Refractometer, Ophthalmic | 6 |
| KPX | Changer, Radiographic Film/Cassette | 5 |
| OWB | Interventional Fluoroscopic X-Ray System | 4 |
| HKX | Tonometer, Ac-Powered | 2 |
| HLI | Ophthalmoscope, Ac-Powered | 2 |
| HLQ | Keratoscope, Ac-Powered | 2 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 2 |
| HFI | Coagulator, Culdoscopic (And Accessories) | 1 |
| HJI | Lens, Fundus, Hruby, Diagnostic | 1 |
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | 1 |
| HKN | Refractor, Manual, Non-Powered, Including Phoropter | 1 |
| HLM | Instrument, Measuring, Lens, Ac-Powered | 1 |
| HOS | Projector, Ophthalmic | 1 |
| HOX | Chart, Visual Acuity | 1 |
| IJZ | Oil, Clearing | 1 |
| IXK | System, Imaging, X-Ray, Electrostatic | 1 |
| IZJ | Camera, X-Ray, Fluorographic, Cine Or Spot | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 30, 2026 | K252503 | Intelligent NR Canon, Inc., JP | OWB |
| May 15, 2024 | K241049 | CANON Fundus Camera CR-10 (CR-10) Canon, Inc., JP | HKI |
| Apr 26, 2024 | K232298 | DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl Canon, Inc., JP | OWB |
| Feb 15, 2023 | K230175 | Digital Radiography CXDI-CS01 Canon, Inc., JP | MQB |
| Oct 17, 2022 | K222855 | Digital Radiography CXDI-Pro, Digital Radiography D1 Canon, Inc., JP | MQB |
| Sep 29, 2022 | K222687 | Digital Radiography CXDI-Elite, Digital Radiography E1 Canon, Inc., JP | MQB |
| Sep 27, 2022 | K222661 | Digital Radiography CXDI-CS01 Canon, Inc., JP | MQB |
| Jul 15, 2022 | K221876 | Digital Radiography CXDI-Pro, Digital Radiography D1 Canon, Inc., JP | MQB |
| Jun 14, 2022 | K221620 | Digital Radiography CXDI-Elite, Digital Radiography E1 Canon, Inc., JP | MQB |
| Feb 4, 2022 | K220098 | Digital Radiography CXDI-Pro, Digital Radiography D1 Canon, Inc., JP | MQB |
| Jan 24, 2022 | K213780 | DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1 Canon, Inc., JP | MQB |
| Sep 17, 2021 | K212269 | Intelligent NR Canon, Inc., JP | MQB |
| Sep 9, 2021 | K212553 | DIGITAL RADIOGRAPHY CXDI-Pro, D1 Canon, Inc., JP | MQB |
| Jan 26, 2021 | K203849 | General Radiography CXDI-CS01 Canon, Inc., JP | MQB |
| Sep 25, 2020 | K201273 | ImageSPECTRUM Canon, Inc., JP | NFJ |
| Jul 23, 2020 | K201122 | Canon non-mydriatic retinal camera CR series Canon, Inc., JP | HKI |
| Apr 15, 2020 | K200887 | AS-10 Canon, Inc., JP | OWB |
| Nov 7, 2019 | K192632 | DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C Wireless Canon, Inc., JP | MQB |
| Jul 24, 2019 | K182942 | Canon OCT-A1 Canon, Inc., JP | OBO |
| Mar 13, 2019 | K190368 | Enhanced Feature Software Pack CXDI Series Canon, Inc., JP | MQB |
| Nov 17, 2017 | K171270 | DIGITAL RADIOGRAPHY CXDI-410C WIRELESS Canon, Inc., JP | MQB |
| May 24, 2017 | K171194 | AS-10, CXDI-401RF Canon, Inc., JP | OWB |
| Mar 1, 2017 | K170332 | DIGITAL RADIOGRAPHY CXDI-710C WIRELESS, DIGITAL RADIOGRAPHY CXDI-810C WIRELESS Canon, Inc., JP | MQB |
| Jun 28, 2016 | K153312 | SCATTER CORRECTION FOR CXDI SERIES Canon, Inc., JP | MQB |
| Jan 22, 2015 | K143718 | Mammography Color Display DP-M3010 Canon, Inc., JP | PGY |
| Jul 1, 2014 | K133693 | DIGITAL RADIOGRAPHY CXDI-401C WIRELESS Canon, Inc. | MQB |
| Jul 3, 2013 | K131106 | DIGITAL RADIOGRAPHY CXDI-701C WIRELESS, DIGITAL RADIOGRAPHY CXDI-70IG WIRELESS, DIGITAL RADIOGRAPHY CXDI-801C WIRELESS, Canon, Inc. | MQB |
| Sep 14, 2011 | K111612 | DIGITAL RETINAL CAMERA Canon, Inc., JP | HKI |
| Jun 15, 2009 | K091545 | DIGITAL RADIOGRAPHY CXDI-60C Canon, Inc. | MQB |
| May 29, 2009 | K091436 | DIGITAL RADIOGRAPHY, MODEL CXDI-55C Canon, Inc. | MQB |
| May 29, 2009 | K091435 | DIGITAL RADIOGRAPHY MODEL CXDI-55G Canon, Inc. | MQB |
| Mar 24, 2009 | K090623 | DIGITAL RADIOGRAPHY CXDI-40G COMPACT Canon USA, Inc. | MQB |
| Mar 23, 2009 | K090466 | DIGITAL RETINAL CAMERA, CR-1 MARK II Canon, Inc. | HKI |
| Jun 24, 2008 | K081648 | DIGITAL RADIOGRAPHY CXDI-60G Canon, Inc. | MQB |
| Apr 24, 2008 | K080883 | CR-1 Canon, Inc. | HKI |
| Jan 23, 2007 | K063717 | CF-1 Canon, Inc. | HKI |
| Aug 17, 2006 | K062221 | CXDI-40EC Canon, Inc. | MQB |
| Mar 10, 2006 | K060433 | DIGITAL RADIOGRAPHY CXDI-50C Canon, Inc. | MQB |
| Apr 27, 2005 | K050987 | DIGITAL RADIOGRAPHY MODEL CXDI-40EG Canon, Inc. | MQB |
| Jun 23, 2004 | K041546 | DIGITAL FUNDUS CAMERA, MODEL CF-60DSI Canon, Inc. | HKI |
| Dec 15, 2003 | K033624 | PACS SOFTWARE SOLUTION 2003 Canon USA, Inc. | LLZ |
| Jun 11, 2003 | K031633 | CANON INC., DIGITAL RADIOGRAPHY, MODEL CXDI-40C Canon USA, Inc. | MQB |
| Jun 6, 2003 | K031629 | CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI Canon USA, Inc. | HKI |
| May 21, 2003 | K031447 | CANON, DIGITAL RADIOGRAPHY, MODEL CXDI-50G Canon, Inc. | MQB |
| Nov 22, 2002 | K023750 | CANNON DIGITAL RADIOGRAPHY MODEL CXDI-40G Canon USA, Inc. | MQB |
| Nov 5, 2002 | K023586 | DR-ER VERFSION OF CANON X-RAY DIGITAL CAMERAS Canon USA, Inc. | MQB |
| Oct 4, 2002 | K023124 | CANON X-RAY DIGITAL CAMERA WITH ADDITIONAL SOFTWARE, LANMIX MLT Canon, Inc., JP | MQB |
| Jan 2, 2002 | K003689 | CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31 Canon USA, Inc. | IXK |
| Jun 21, 2000 | K992606 | CANON LASER BLOOD FLOWMETER (CLBF) MODEL 100 Canon USA, Inc. | HLI |
| Oct 13, 1999 | K992547 | CANON X-RAY DIGITAL CAMERA, MODEL CXDI-22 Canon USA, Inc. | MQB |
Newest 50 of 91.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 25, 2013 | Canon Inc. Canon Full Auto Ref-Keratometer RK-F2, Catalog Number 6937B002AA.
Product Usage: This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human e Terminated |
HKO | None listed |
| Aug 24, 2012 | Canon Inc. Canon Solid State X-ray Imager (Flat Panel/Digital Imager), Digital Radiography, Models CXDI-55C, CXDI-55G and CXDI-70C. These devices are intended to replace radiographic film/screen systems in all g Terminated |
MQB | K091435 K091436 +1 |
| Jun 5, 2003 | Canon USA Inc Rational Imaging TM Software, model Ultra 10
PACS System Version 7.1.Xx Terminated |
LMB | None listed |