AQUILION ONE VISION
System, X-ray, Tomography, Computed
TOSHIBA MEDICAL SYSTEMS CORPORATION
The following data is part of a premarket notification filed by Toshiba Medical Systems Corporation with the FDA for Aquilion One Vision.
Pre-market Notification Details
| Device ID | K133497 |
| 510k Number | K133497 |
| Device Name: | AQUILION ONE VISION |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | TOSHIBA MEDICAL SYSTEMS CORPORATION 2441 MICHELLE DRIVE Tustin, CA 92780 |
| Contact | Paul Biggins |
| Correspondent | Paul Biggins TOSHIBA MEDICAL SYSTEMS CORPORATION 2441 MICHELLE DRIVE Tustin, CA 92780 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-14 |
| Decision Date | 2014-02-10 |
| Summary: | summary |
Trademark Results [AQUILION ONE VISION]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AQUILION ONE VISION 79127770 4394518 Live/Registered |
Canon Medical Systems Corporation 2013-02-18 |
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