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 |
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![]() AQUILION EXCEED LB 79287817 not registered Live/Pending |
Canon Medical Systems Corporation 2020-03-05 |