Device Classification Name |
Interventional Fluoroscopic X-Ray System
|
510(k) Number |
K181415 |
Device Name |
XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0 |
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 |
Jannie F. Reyes |
Regulation Number | 892.1650 |
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/30/2018 |
Decision Date | 09/10/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|