The following data is part of a premarket notification filed by Toshiba Medical Systems Corporation, Japan with the FDA for Aquilion Premium.
| Device ID | K120546 |
| 510k Number | K120546 |
| Device Name: | AQUILION PREMIUM |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN 2441 MICHELLE DR Tustin, CA 92780 |
| Contact | Paul Biggins |
| Correspondent | Paul Biggins TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN 2441 MICHELLE DR Tustin, CA 92780 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-23 |
| Decision Date | 2012-06-13 |
| Summary: | summary |