The following data is part of a premarket notification filed by Toshiba Medical Systems Coporation, Japan with the FDA for Aquilion One.
| Device ID | K113466 |
| 510k Number | K113466 |
| Device Name: | AQUILION ONE |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN 2441 MICHELLE DR Tustin, CA 92780 |
| Contact | Paul Biggins |
| Correspondent | Paul Biggins TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN 2441 MICHELLE DR 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 | 2011-11-22 |
| Decision Date | 2012-04-10 |