The following data is part of a premarket notification filed by Toshiba America Medical Systems, Inc. with the FDA for Aquilion One Vision, V4.90.
| Device ID | K122109 |
| 510k Number | K122109 |
| Device Name: | AQUILION ONE VISION, V4.90 |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR Tustin, CA 92780 |
| Contact | Paul Biggins |
| Correspondent | Paul Biggins TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 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 | 2012-07-17 |
| Decision Date | 2012-09-21 |
| Summary: | summary |