Device Classification Name |
system, x-ray, stationary
|
510(k) Number |
K233719 |
Device Name |
FDR Visionary Suite |
Applicant |
Shimadzu Corporation |
1 Nishinokyo Kuwabara-cho, Nakagyo-ku |
Kyoto,
JP
604-8511
|
|
Applicant Contact |
Koichi Kataoka |
Correspondent |
Kamm & Associates |
8870 Ravello Ct. |
Naples,
FL
34114
|
|
Correspondent Contact |
Daniel Kamm |
Regulation Number | 892.1680
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/21/2023 |
Decision Date | 03/28/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|