Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Canon, Inc. — Predicate Candidate Screening
43 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
26 daysmedian FDA review time
224 days90th percentile
43clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252503 | Intelligent NR | Canon, Inc. | 2026-04-30 | 265 | 0 |
| K241049 | CANON Fundus Camera CR-10 (CR-10) | Canon, Inc. | 2024-05-15 | 28 | 0 |
| K232298 | DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl | Canon, Inc. | 2024-04-26 | 269 | 0 |
| K230175 | Digital Radiography CXDI-CS01 | Canon, Inc. | 2023-02-15 | 26 | 0 |
| K222855 | Digital Radiography CXDI-Pro, Digital Radiography D1 | Canon, Inc. | 2022-10-17 | 26 | 0 |
| K222687 | Digital Radiography CXDI-Elite, Digital Radiography E1 | Canon, Inc. | 2022-09-29 | 23 | 0 |
| K222661 | Digital Radiography CXDI-CS01 | Canon, Inc. | 2022-09-27 | 25 | 0 |
| K221876 | Digital Radiography CXDI-Pro, Digital Radiography D1 | Canon, Inc. | 2022-07-15 | 17 | 0 |
| K221620 | Digital Radiography CXDI-Elite, Digital Radiography E1 | Canon, Inc. | 2022-06-14 | 11 | 0 |
| K220098 | Digital Radiography CXDI-Pro, Digital Radiography D1 | Canon, Inc. | 2022-02-04 | 23 | 0 |
| K213780 | DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1 | Canon, Inc. | 2022-01-24 | 53 | 0 |
| K212269 | Intelligent NR | Canon, Inc. | 2021-09-17 | 59 | 0 |
| K212553 | DIGITAL RADIOGRAPHY CXDI-Pro, D1 | Canon, Inc. | 2021-09-09 | 27 | 0 |
| K203849 | General Radiography CXDI-CS01 | Canon, Inc. | 2021-01-26 | 26 | 0 |
| K201273 | ImageSPECTRUM | Canon, Inc. | 2020-09-25 | 136 | 0 |
| K201122 | Canon non-mydriatic retinal camera CR series | Canon, Inc. | 2020-07-23 | 87 | 0 |
| K200887 | AS-10 | Canon, Inc. | 2020-04-15 | 13 | 0 |
| K192632 | DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY | Canon, Inc. | 2019-11-07 | 45 | 0 |
| K182942 | Canon OCT-A1 | Canon, Inc. | 2019-07-24 | 274 | 0 |
| K190368 | Enhanced Feature Software Pack CXDI Series | Canon, Inc. | 2019-03-13 | 26 | 0 |
| K171270 | DIGITAL RADIOGRAPHY CXDI-410C WIRELESS | Canon, Inc. | 2017-11-17 | 200 | 0 |
| K171194 | AS-10, CXDI-401RF | Canon, Inc. | 2017-05-24 | 30 | 0 |
| K170332 | DIGITAL RADIOGRAPHY CXDI-710C WIRELESS, DIGITAL RADIOGRAPHY | Canon, Inc. | 2017-03-01 | 27 | 0 |
| K153312 | SCATTER CORRECTION FOR CXDI SERIES | Canon, Inc. | 2016-06-28 | 224 | 0 |
| K143718 | Mammography Color Display DP-M3010 | Canon, Inc. | 2015-01-22 | 24 | 0 |
| K133693 | DIGITAL RADIOGRAPHY CXDI-401C WIRELESS | Canon, Inc. | 2014-07-01 | 210 | 0 |
| K131106 | DIGITAL RADIOGRAPHY CXDI-701C WIRELESS, DIGITAL RADIOGRAPHY | Canon, Inc. | 2013-07-03 | 75 | 0 |
| K111612 | DIGITAL RETINAL CAMERA | Canon, Inc. | 2011-09-14 | 97 | 0 |
| K091545 | DIGITAL RADIOGRAPHY CXDI-60C | Canon, Inc. | 2009-06-15 | 19 | 0 |
| K091435 | DIGITAL RADIOGRAPHY MODEL CXDI-55G | Canon, Inc. | 2009-05-29 | 15 | 1 |
| K091436 | DIGITAL RADIOGRAPHY, MODEL CXDI-55C | Canon, Inc. | 2009-05-29 | 15 | 1 |
| K090466 | DIGITAL RETINAL CAMERA, CR-1 MARK II | Canon, Inc. | 2009-03-23 | 30 | 0 |
| K081648 | DIGITAL RADIOGRAPHY CXDI-60G | Canon, Inc. | 2008-06-24 | 12 | 0 |
| K080883 | CR-1 | Canon, Inc. | 2008-04-24 | 24 | 0 |
| K063717 | CF-1 | Canon, Inc. | 2007-01-23 | 40 | 0 |
| K062221 | CXDI-40EC | Canon, Inc. | 2006-08-17 | 15 | 0 |
| K060433 | DIGITAL RADIOGRAPHY CXDI-50C | Canon, Inc. | 2006-03-10 | 17 | 0 |
| K050987 | DIGITAL RADIOGRAPHY MODEL CXDI-40EG | Canon, Inc. | 2005-04-27 | 8 | 0 |
| K041546 | DIGITAL FUNDUS CAMERA, MODEL CF-60DSI | Canon, Inc. | 2004-06-23 | 14 | 0 |
| K031447 | CANON, DIGITAL RADIOGRAPHY, MODEL CXDI-50G | Canon, Inc. | 2003-05-21 | 14 | 0 |
| K023124 | CANON X-RAY DIGITAL CAMERA WITH ADDITIONAL SOFTWARE, LANMIX | Canon, Inc. | 2002-10-04 | 15 | 0 |
| K943939 | NON-CONTACT TONOMETER T-2 | Canon, Inc. | 1995-05-12 | 273 | 0 |
| K940516 | AUTO REFF-30 | Canon, Inc. | 1994-07-12 | 158 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda