The following data is part of a premarket notification filed by Toshiba America Medical Systems, Inc. with the FDA for Aquilion One Tsx-301a/2 Computed Tomography System.
| Device ID | K072606 |
| 510k Number | K072606 |
| Device Name: | AQUILION ONE TSX-301A/2 COMPUTED TOMOGRAPHY SYSTEM |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. Tustin, CA 92780 |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-09-17 |
| Decision Date | 2007-10-02 |
| Summary: | summary |