The following data is part of a premarket notification filed by Canon Medical Systems Corporation with the FDA for Aquilion Exceed Lb.
| Device ID | K211828 | 
| 510k Number | K211828 | 
| Device Name: | Aquilion Exceed LB | 
| Classification | System, X-ray, Tomography, Computed | 
| Applicant | Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi, JP 324-8550 | 
| Contact | Paul Biggins | 
| Correspondent | Orlando Tadeo, Jr. Canon Medical Systems USA 2441 Michelle Drive 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 | 2021-06-14 | 
| Decision Date | 2021-09-10 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  AQUILION EXCEED LB  79287817  not registered Live/Pending | Canon Medical Systems Corporation 2020-03-05 |