The following data is part of a premarket notification filed by Shimadzu Corporation with the FDA for Fdr Visionary Suite.
Device ID | K152294 |
510k Number | K152294 |
Device Name: | FDR Visionary Suite |
Classification | System, X-ray, Stationary |
Applicant | SHIMADZU CORPORATION 1 NISHINOKYO-KUWABARACHO NAKAGYO-KU Kyoto, JP 604-8511 |
Contact | Toshio Kadowaki |
Correspondent | Toshio Kadowaki SHIMADZU MEDICAL SYSTEMS 1, Nishinokyo-Kuwabaracho, Nakagyo-ku Kyoto, JP |
Product Code | KPR |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-08-13 |
Decision Date | 2016-07-15 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04540217057450 | K152294 | 000 |
04540217064700 | K152294 | 000 |
04540217064717 | K152294 | 000 |
04540217064724 | K152294 | 000 |
04540217052202 | K152294 | 000 |
04540217052219 | K152294 | 000 |
04540217052226 | K152294 | 000 |
04540217057436 | K152294 | 000 |
04540217057443 | K152294 | 000 |
04540217064694 | K152294 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
FDR VISIONARY SUITE 86312188 5191573 Live/Registered |
FUJIFILM Medical Systems U.S.A., Inc. 2014-06-17 |