Canon Inc. -Medical Equipment Group: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Canon Inc. -Medical Equipment Group” (first 2010, latest 2018), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 89 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 193 |
| 2013 | 1 | 158 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 84 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Canon Inc. -Medical Equipment Group took a median 84 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 56 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 5 | 5 |
| HKI | Camera, Ophthalmic, Ac-Powered | 2 | 2 |
| HKX | Tonometer, Ac-Powered | 1 | 1 |
| NFJ | System, Image Management, Ophthalmic | 1 | 1 |
| OXO | Image-Intensified Fluoroscopic X-Ray System, Mobile | 1 | 1 |
Review panels
- Radiology (6)
- Ophthalmic (4)
Most recent Canon Inc. -Medical Equipment Group 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K173689 | Ophthalmic Software Platform RX | NFJ | 2018-02-23 | 84 |
| K123208 | DIGITAL RETINAL CAMERA | HKI | 2013-03-19 | 158 |
| K121303 | MOBILE C-ARM | OXO | 2012-07-26 | 86 |
| K111824 | FLAT PANEL DETECTOR | MQB | 2012-04-23 | 300 |
| K111710 | FULL AUTO TONOMETER MODEL TX-20 | HKX | 2011-09-20 | 92 |
| K112309 | DIGITAL RADIOGRAPHY | MQB | 2011-09-02 | 22 |
| K111682 | DIGITAL RADIOGRAPHY | MQB | 2011-09-02 | 79 |
| K103591 | DIGITAL RADIOGRAPHY | MQB | 2011-03-29 | 112 |
| K102013 | DIGITAL RETINAL CAMERA | HKI | 2010-10-29 | 105 |
| K102012 | DIGITAL RADIOGRAPHY | MQB | 2010-08-17 | 32 |
Recalls
openFDA lists no recalls under a recalling firm named Canon Inc. -Medical Equipment Group.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Canon Medical Systems Corporation (97 510(k)s)
- Canon USA, Inc. (48 510(k)s)
- Canon, Inc. (43 510(k)s)
- Canon Medical Informatics, Inc. (5 510(k)s)
- Canon Components, Inc. (1 510(k)s)
- Canon, Inc. Medical Equipment Group (1 510(k)s)
- Canon, Inc. - Medical Equpment Group (1 510(k)s)
- Canon, Inc.-Utsunomiya Optical Products Operation (1 510(k)s)
- Canon Medical Systems, USA (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Canon Inc. -Medical Equipment Group?
FDA lists 10 510(k) clearances under the applicant name “Canon Inc. -Medical Equipment Group” (first 2010, latest 2018), across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Canon Inc. -Medical Equipment Group?
The median time from FDA receipt to decision across 510(k)s cleared under the name Canon Inc. -Medical Equipment Group is 89 days.
Which FDA product codes appear under Canon Inc. -Medical Equipment Group?
The most frequent FDA product codes under this applicant name are MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager), 5); HKI (Camera, Ophthalmic, Ac-Powered, 2); HKX (Tonometer, Ac-Powered, 1).
Next steps
- See all 10 Canon Inc. -Medical Equipment Group clearances with predicates and recalls
- Run predicate analysis for product code MQB, Canon Inc. -Medical Equipment Group's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.