Canon USA, Inc.: FDA clearances and approvals
Canon USA, Inc. has 48 FDA 510(k) clearances (first 1984, latest 2009), across 21 product codes in 4 review panels. Median 510(k) review time: 62 days. openFDA lists 1 product recall by a recalling firm named Canon USA, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HKI | Camera, Ophthalmic, Ac-Powered | 12 | 12 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 6 | 6 |
| KPX | Changer, Radiographic Film/Cassette | 5 | 5 |
| HKO | Refractometer, Ophthalmic | 4 | 4 |
| HLI | Ophthalmoscope, Ac-Powered | 2 | 2 |
| HLQ | Keratoscope, Ac-Powered | 2 | 2 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | 2 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 2 | 2 |
| HFI | Coagulator, Culdoscopic (And Accessories) | 1 | 1 |
| HJI | Lens, Fundus, Hruby, Diagnostic | 1 | 1 |
Plus 11 more product codes.
Review panels
- Ophthalmic (27)
- Radiology (18)
- Hematology (1)
- Obstetrics and Gynecology (1)
Most recent Canon USA, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K090623 | DIGITAL RADIOGRAPHY CXDI-40G COMPACT | MQB | 2009-03-24 | 15 |
| K033624 | PACS SOFTWARE SOLUTION 2003 | LLZ | 2003-12-15 | 27 |
| K031633 | CANON INC., DIGITAL RADIOGRAPHY, MODEL CXDI-40C | MQB | 2003-06-11 | 15 |
| K031629 | CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI | HKI | 2003-06-06 | 10 |
| K023750 | CANNON DIGITAL RADIOGRAPHY MODEL CXDI-40G | MQB | 2002-11-22 | 14 |
| K023586 | DR-ER VERFSION OF CANON X-RAY DIGITAL CAMERAS | MQB | 2002-11-05 | 11 |
| K003689 | CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31 | IXK | 2002-01-02 | 398 |
| K992606 | CANON LASER BLOOD FLOWMETER (CLBF) MODEL 100 | HLI | 2000-06-21 | 323 |
| K992547 | CANON X-RAY DIGITAL CAMERA, MODEL CXDI-22 | MQB | 1999-10-13 | 75 |
| K981556 | CANON X-RAY DIGITAL CAMERA CXDI-11 | MQB | 1998-11-04 | 187 |
38 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2003-03-11.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Canon USA, Inc. have?
Canon USA, Inc. has 48 FDA 510(k) clearances (first 1984, latest 2009), across 21 product codes in 4 review panels.
How long does FDA take to clear Canon USA, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Canon USA, Inc.'s cleared 510(k)s is 62 days.
What devices does Canon USA, Inc. make?
Its most frequent FDA product codes are HKI (Camera, Ophthalmic, Ac-Powered, 12); MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager), 6); KPX (Changer, Radiographic Film/Cassette, 5).
Has Canon USA, Inc. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Canon USA, Inc; the most recent began 2003-03-11. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 48 Canon USA, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HKI, Canon USA, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.