The following data is part of a premarket notification filed by Toshiba America Medical Systems, Inc. with the FDA for Aquilion Prime.
Device ID | K110066 |
510k Number | K110066 |
Device Name: | AQUILION PRIME |
Classification | System, X-ray, Tomography, Computed |
Applicant | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. P.O. BOX 2068 Tustin, CA 92781 -2068 |
Contact | Paul Biggins |
Correspondent | Paul Biggins TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. P.O. BOX 2068 Tustin, CA 92781 -2068 |
Product Code | JAK |
CFR Regulation Number | 892.1750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-01-10 |
Decision Date | 2012-01-26 |
Summary: | summary |