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 |