Device Classification Name |
System, X-Ray, Tomography, Computed
|
510(k) Number |
K223726 |
Device Name |
Aquilion Precision (TSX-304A/4) V10.14 with AiCE |
Applicant |
Canon Medical Systems Corporation |
1385 Shimoishigami |
Otawara-shi,
JP
324-8550
|
|
Applicant Contact |
Paul Biggins |
Correspondent |
Canon Medical Systems USA |
2441 Michelle Drive |
Tustin,
CA
92780
|
|
Correspondent Contact |
Orlando Tadeo |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 12/13/2022 |
Decision Date | 03/07/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|