Device Classification Name |
system, x-ray, stationary
|
510(k) Number |
K152294 |
Device Name |
FDR Visionary Suite |
Applicant |
SHIMADZU CORPORATION |
1 NISHINOKYO-KUWABARACHO NAKAGYO-KU |
KYOTO,
JP
604-8511
|
|
Applicant Contact |
TOSHIO KADOWAKI |
Correspondent |
SHIMADZU MEDICAL SYSTEMS |
1, Nishinokyo-Kuwabaracho, Nakagyo-ku |
Kyoto,
JP
|
|
Correspondent Contact |
Toshio Kadowaki |
Regulation Number | 892.1680
|
Classification Product Code |
|
Date Received | 08/13/2015 |
Decision Date | 07/15/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|