Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Canon USA, Inc. · Predicate Candidate Screening
48 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
63 daysmedian FDA review time
273 days90th percentile
48clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K090623 | DIGITAL RADIOGRAPHY CXDI-40G COMPACT | Canon USA, Inc. | 2009-03-24 | 15 | 0 |
| K033624 | PACS SOFTWARE SOLUTION 2003 | Canon USA, Inc. | 2003-12-15 | 27 | 0 |
| K031633 | CANON INC., DIGITAL RADIOGRAPHY, MODEL CXDI-40C | Canon USA, Inc. | 2003-06-11 | 15 | 0 |
| K031629 | CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI | Canon USA, Inc. | 2003-06-06 | 10 | 0 |
| K023750 | CANNON DIGITAL RADIOGRAPHY MODEL CXDI-40G | Canon USA, Inc. | 2002-11-22 | 14 | 0 |
| K023586 | DR-ER VERFSION OF CANON X-RAY DIGITAL CAMERAS | Canon USA, Inc. | 2002-11-05 | 11 | 0 |
| K003689 | CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31 | Canon USA, Inc. | 2002-01-02 | 398 | 0 |
| K992606 | CANON LASER BLOOD FLOWMETER (CLBF) MODEL 100 | Canon USA, Inc. | 2000-06-21 | 323 | 0 |
| K992547 | CANON X-RAY DIGITAL CAMERA, MODEL CXDI-22 | Canon USA, Inc. | 1999-10-13 | 75 | 0 |
| K981556 | CANON X-RAY DIGITAL CAMERA CXDI-11 | Canon USA, Inc. | 1998-11-04 | 187 | 0 |
| K980246 | NON-MYDRIATIC RETINAL CAMERA, MODEL CR6-45NM | Canon USA, Inc. | 1998-05-06 | 103 | 0 |
| K963079 | CANON TX-10 TONOMETER | Canon USA, Inc. | 1997-03-03 | 208 | 0 |
| K941234 | NON-MYDRIATIC RETINAL CAMERA | Canon USA, Inc. | 1995-06-07 | 449 | 0 |
| K946058 | 60 FUNDUS CAMERA CF-60UV | Canon USA, Inc. | 1995-02-03 | 87 | 0 |
| K945635 | TRANS X-1000 | Canon USA, Inc. | 1995-02-01 | 77 | 0 |
| K936200 | WIRELESS CHART PROJECTOR,HCP-W 721 | Canon USA, Inc. | 1994-09-28 | 273 | 0 |
| K936199 | AUTOMATIC LENSOMETER | Canon USA, Inc. | 1994-09-28 | 273 | 0 |
| K936205 | COMPREHENSIVE PHOROPTER, MDR-680 | Canon USA, Inc. | 1994-09-28 | 273 | 0 |
| K936209 | SLIT LAMP, H-201 | Canon USA, Inc. | 1994-04-01 | 93 | 0 |
| K934663 | 60 DEGREE FUNDUS CAMERA, CF-60UD | Canon USA, Inc. | 1994-02-22 | 147 | 0 |
| K925304 | AUTOREF LENSMETER RL-10 | Canon USA, Inc. | 1994-02-17 | 484 | 0 |
| K911439 | NON-MYDRIATIC RETINAL CAMERA, CR-45UAF | Canon USA, Inc. | 1991-06-17 | 76 | 0 |
| K901839 | 60 FUNDUS CAMERA CF-60UV | Canon USA, Inc. | 1990-07-05 | 72 | 0 |
| K895475 | CANON AUTO REF-KERATOMETER RK-2 | Canon USA, Inc. | 1989-10-31 | 50 | 0 |
| K895474 | NON-MYDRIATIC RETINAL CAMERA, CR4-45NM DUAL | Canon USA, Inc. | 1989-10-04 | 23 | 0 |
| K891225 | OPTIONAL PROBE OF CANON IOL ESTIMATOR KU-1 | Canon USA, Inc. | 1989-05-31 | 85 | 0 |
| K881889 | CANON IOL ESTIMATOR KU-1 | Canon USA, Inc. | 1988-09-15 | 133 | 0 |
| K883200 | CANON AUTOREFRACTOMETER R-22 | Canon USA, Inc. | 1988-08-18 | 21 | 0 |
| K882287 | CANON AUTOREFRACTOMETER R-20 | Canon USA, Inc. | 1988-07-01 | 30 | 0 |
| K874017 | MODIFIED RETINAL CAMERA MODEL CR4-45NM | Canon USA, Inc. | 1987-11-02 | 31 | 0 |
| K871936 | CANON SURGICAL AUTO KERATOMETER SK-1 | Canon USA, Inc. | 1987-06-19 | 32 | 0 |
| K871119 | CANON X-RAY IMAGE DISTRIBUTOR CXI-3-3D | Canon USA, Inc. | 1987-03-31 | 12 | 0 |
| K870048 | ADDITIONAL MODEL TO CANON UNIVERSAL STAND | Canon USA, Inc. | 1987-01-12 | 6 | 0 |
| K862323 | CANON NON-MYDRIATIC RETINAL CAMERA CR4-45NM | Canon USA, Inc. | 1986-08-21 | 63 | 0 |
| K862575 | UNIVERSAL STAND FOR FILM CHANGER | Canon USA, Inc. | 1986-07-14 | 7 | 0 |
| K861416 | CANON AUTO ACUITOMETER CV-10 | Canon USA, Inc. | 1986-05-14 | 29 | 0 |
| K861415 | CANON AUTO REF KERATOMETER RK-1 | Canon USA, Inc. | 1986-05-14 | 29 | 0 |
| K855170 | CANON NON-MYDRIATIC RETINAL CAMERA CR3-45NM | Canon USA, Inc. | 1986-02-27 | 63 | 0 |
| K853928 | UNIVERSAL STAND FOR FILM CHANGER | Canon USA, Inc. | 1985-10-28 | 34 | 0 |
| K853861 | CANON X-RAY I.I. RAPID SEQUENCE CAMERA CRS-105 | Canon USA, Inc. | 1985-10-24 | 37 | 0 |
| K853984 | CANON X-RAY IMAGE DISTRIBUTOR | Canon USA, Inc. | 1985-10-16 | 19 | 0 |
| K853983 | CANON X-RAY 35MM CINE CAMERA CSI-35 | Canon USA, Inc. | 1985-10-16 | 19 | 0 |
| K851067 | CANON X-RAY FILM CHANGER CFC-U1 | Canon USA, Inc. | 1985-05-21 | 64 | 0 |
| K844898 | CANON 60 ZOOM FUNDUS CAMERA CF-60ZA OPHTHALMIC CAM | Canon USA, Inc. | 1985-01-22 | 36 | 0 |
| K844053 | CANON 60 DEGREE FUNDUS CAMERA CF-60S | Canon USA, Inc. | 1984-12-19 | 62 | 0 |
| K844054 | CANON AUTO KERATOMETER K-1 | Canon USA, Inc. | 1984-12-19 | 62 | 0 |
| K841861 | CANON AUTOREF R-10 | Canon USA, Inc. | 1984-10-05 | 154 | 0 |
| K843021 | CANON 60 FUNDUS CAMERA CF-60U | Canon USA, Inc. | 1984-10-05 | 65 | 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