FDR Visionary Suite
System, X-ray, Stationary
SHIMADZU CORPORATION
The following data is part of a premarket notification filed by Shimadzu Corporation with the FDA for Fdr Visionary Suite.
Pre-market Notification Details
| 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 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04540217057450 | K152294 | 000 |
| 04540217064489 | K152294 | 000 |
| 04540217064496 | K152294 | 000 |
| 04540217064502 | K152294 | 000 |
| 04540217064694 | 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 |
| 04540217064472 | K152294 | 000 |
Trademark Results [FDR Visionary Suite]
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 |
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