Trinias
Interventional Fluoroscopic X-ray System
Shimadzu Corporation Medical Systems Division
The following data is part of a premarket notification filed by Shimadzu Corporation Medical Systems Division with the FDA for Trinias.
Pre-market Notification Details
| Device ID | K221922 |
| 510k Number | K221922 |
| Device Name: | Trinias |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | Shimadzu Corporation Medical Systems Division 1, Nishinokyo-Kuwabaracho, Nakagyo-ku Kyoto, JP 604-8511 |
| Contact | Koichi Kataoka |
| Correspondent | Daniel Kamm Kamm & Associates 8870 Ravello Ct Naples, FL 34114 |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-01 |
| Decision Date | 2022-07-28 |
Trademark Results [Trinias]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRINIAS 86707621 4972141 Live/Registered |
SHIMADZU CORPORATION 2015-07-28 |
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