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 |