Canon Medical Systems Corporation: FDA filings under this applicant name
FDA lists 97 510(k) clearances under the applicant name “Canon Medical Systems Corporation” (first 2018, latest 2026), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 84 days. Since 2017 the median was 84 days, against 115 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.
Caduvo groups this applicant name under Canon Medical Systems, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 15 | 43 |
| 2019 | 10 | 69 |
| 2020 | 15 | 85 |
| 2021 | 15 | 60 |
| 2022 | 10 | 118 |
| 2023 | 10 | 86 |
| 2024 | 8 | 122 |
| 2025 | 9 | 121 |
| 2026 | 5 | 113 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Canon Medical Systems Corporation 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 115 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | 31 | 31 |
| JAK | System, X-Ray, Tomography, Computed | 23 | 23 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 17 | 17 |
| OWB | Interventional Fluoroscopic X-Ray System | 12 | 12 |
| LLZ | System, Image Processing, Radiological | 7 | 7 |
| KPS | System, Tomography, Computed, Emission | 5 | 5 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 1 | 1 |
| QIH | Automated Radiological Image Processing Software | 1 | 1 |
Review panels
- Radiology (97)
Most recent Canon Medical Systems Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253596 | Aquilion ONE (TSX-308A/TSX-306A) V2.0 | JAK | 2026-05-20 | 183 |
| K253625 | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR | LNH | 2026-03-27 | 129 |
| K260078 | Aquilion ServeSP (TSX-307B) V2.0 | JAK | 2026-03-13 | 60 |
| K253584 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) | OWB | 2026-03-10 | 113 |
| K253597 | Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System | IYN | 2026-01-20 | 63 |
| K251370 | Cartesion Prime (PCD-1000A/3) V10.21 | KPS | 2025-12-01 | 213 |
| K252074 | Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System | IYN | 2025-10-31 | 121 |
| K251602 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging | OWB | 2025-10-10 | 136 |
| K251645 | Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP | JAK | 2025-09-26 | 120 |
| K250901 | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR | LNH | 2025-07-22 | 118 |
87 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Canon Medical Systems Corporation.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Canon Medical Systems Corporation (a text match, not an official crosswalk):
- C8903 — Magnetic resonance imaging with contrast, breast; unilateral (via LNH)
- C8906 — Magnetic resonance imaging with contrast, breast; bilateral (via LNH)
- C8905 — Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral (via LNH)
- C8908 — Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral (via LNH)
- C8900 — Magnetic resonance angiography with contrast, abdomen (via LNH)
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 USA, Inc. (48 510(k)s)
- Canon, Inc. (43 510(k)s)
- Canon Inc. -Medical Equipment Group (10 510(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 Medical Systems Corporation?
FDA lists 97 510(k) clearances under the applicant name “Canon Medical Systems Corporation” (first 2018, latest 2026), across 8 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 Systems Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Canon Medical Systems Corporation is 84 days. Since 2017: 84 days, versus 115 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Canon Medical Systems Corporation?
The most frequent FDA product codes under this applicant name are LNH (System, Nuclear Magnetic Resonance Imaging, 31); JAK (System, X-Ray, Tomography, Computed, 23); IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 17).
Next steps
- See all 97 Canon Medical Systems Corporation clearances with predicates and recalls
- Run predicate analysis for product code LNH, Canon Medical Systems Corporation'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.