Medical device manufacturer
Canon Medical Systems Corporation
Canon Medical Systems Corporation holds 97 FDA 510(k) clearances across 8 product codes. Median elapsed review time is 84 days. openFDA lists no recall records naming the company.
Updated · ingest status · JSON
- 510(k) clearances
- 97
- Product codes
- 8
- Median review
- 84 days
- Recall records
- 0
How does FDA spell Canon Medical Systems Corporation?
FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.
Which product codes does Canon Medical Systems Corporation file in?
8 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | 31 | 58 days | |
| JAK | System, X-Ray, Tomography, Computed | 23 | 142 days | |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 17 | 85 days | |
| OWB | Interventional Fluoroscopic X-Ray System | 12 | 30 days | |
| LLZ | System, Image Processing, Radiological | 7 | 84 days | |
| KPS | System, Tomography, Computed, Emission | 5 | 89 days | |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 1 | 22 days | |
| QIH | Automated Radiological Image Processing Software | 1 | 84 days |
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Canon Medical Systems Corporation had a recall?
openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Canon Medical Systems Corporation cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K253596 | Aquilion ONE (TSX-308A/TSX-306A) V2.0 | JAK | 183 | |
| K253625 | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR | LNH | 129 | |
| K260078 | Aquilion ServeSP (TSX-307B) V2.0 | JAK | 60 | |
| K253584 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) | OWB | 113 | |
| K253597 | Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System | IYN | 63 | |
| K251370 | Cartesion Prime (PCD-1000A/3) V10.21 | KPS | 213 | |
| K252074 | Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System | IYN | 121 | |
| K251602 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging | OWB | 136 | |
| K251645 | Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP | JAK | 120 | |
| K250901 | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR | LNH | 118 |
Source: openFDA device/510k · retrieved
Watch what Canon Medical Systems Corporation files next
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