Canon Medical Informatics, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Canon Medical Informatics, Inc.” (first 2022, latest 2026), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 136 days. Since 2017 the median was 136 days, against 130 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2022 | 1 | 42 |
| 2023 | 1 | 262 |
| 2024 | 0 | — |
| 2025 | 2 | 159 |
| 2026 | 1 | 112 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Canon Medical Informatics, Inc. took a median 136 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 130 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | 3 | 3 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
| QIH | Automated Radiological Image Processing Software | 1 | 1 |
Review panels
- Radiology (5)
Most recent Canon Medical Informatics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260324 | Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning | QIH | 2026-05-22 | 112 |
| K252217 | CT VScore+ | JAK | 2025-11-28 | 136 |
| K243240 | Vitrea CT VScore | JAK | 2025-04-10 | 182 |
| K223261 | Open Rib | JAK | 2023-07-13 | 262 |
| K222662 | Vitrea CT Cardiac Analysis | LLZ | 2022-10-14 | 42 |
Recalls
openFDA lists no recalls under a recalling firm named Canon Medical Informatics, Inc..
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 Inc. -Medical Equipment Group (10 510(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 Medical Informatics, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Canon Medical Informatics, Inc.” (first 2022, latest 2026), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Canon Medical Informatics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Canon Medical Informatics, Inc. is 136 days. Since 2017: 136 days, versus 130 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Canon Medical Informatics, Inc.?
The most frequent FDA product codes under this applicant name are JAK (System, X-Ray, Tomography, Computed, 3); LLZ (System, Image Processing, Radiological, 1); QIH (Automated Radiological Image Processing Software, 1).
Next steps
- See all 5 Canon Medical Informatics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JAK, Canon Medical Informatics, Inc.'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.