Device Classification Name |
System, Nuclear Magnetic Resonance Imaging
|
510(k) Number |
K203323 |
Device Name |
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR |
Applicant |
Canon Medical Systems Corporation |
1385 Shimoshigami |
Otawara-shi,
JP
324-8550
|
|
Applicant Contact |
Janine F. Reyes |
Correspondent |
Canon Medical Systems USA, INC. |
2441 Michelle Drive |
Tustin,
CA
92780
|
|
Correspondent Contact |
Janine F. Reyes |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 11/12/2020 |
Decision Date | 03/04/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|