Trinias
FDA 510(k) K123508 · Shimadzu Corporation
510(k) numberK123508
Submission
- Device name
- Trinias
- Applicant
- Shimadzu Corporation
Kyoto, JP - Received
- November 13, 2012
- Decision date
- February 26, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code OWB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253726 | uAngio AVIVA CXOWB · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 08/21/2026SE |
| K261413 | Extron 3;EXTRON 6OWB · Traditional | DRTECH Corporation | 08/19/2026SE |
| K254205 | Zenition 30OWB · Traditional | Philips Medical Systems Nederland B.V. | 08/07/2026SE |
| K260607 | Shield System (Siemens 30x40)OWB · Special | Radiaction , Ltd. | 07/31/2026SE |
| K253670 | SmartCT (R3.0 (L10))OWB · Abbreviated | Philips Medical Systems B.V. | 07/10/2026SE |
| K252735 | C-beamOWB · Traditional | Pulmera, Inc. | 05/22/2026SE |
| K252503 | Intelligent NROWB · Traditional | Canon, Inc. | 04/30/2026SE |
| K254173 | ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoOWB · Traditional | Siemens Medical Solutions USA, Inc. | 04/24/2026SE |
| K253752 | ARTIS genio floor; ARTIS icono.explore floorOWB · Traditional | Siemens Medical Solutions USA, Inc. | 04/23/2026SE |
| K252229 | Belliger AceOWB · Traditional | Genoray Co., Ltd. | 04/02/2026SE |
More from Genoray Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K252099 | TriniasOWB · Abbreviated | 03/24/2026SE |
| K233719 | FDR Visionary SuiteKPR · Traditional | 03/28/2024SE |
| K233722 | RADspeed ProKPR · Traditional | 02/23/2024SE |
| K191877 | FLUOROspeedJAA · Special | 08/05/2019SE |
| K190373 | SonialVision G4JAA · Special | 03/15/2019SE |
| K173517 | RADspeed fitKPR · Traditional | 03/30/2018SE |
| K152294 | FDR Visionary SuiteKPR · Traditional | 07/15/2016SE |
| K152244 | RADspeed ProKPR · Traditional | 06/20/2016SE |
| K142341 | X-Ray TV System Sonialvision G4JAA · Abbreviated | 03/06/2015SE |
| K131075 | X-Ray TV System Sonial Vision G4JAA · Abbreviated | 03/28/2014SE |
Questions and answers
When was Trinias cleared by the FDA?
Trinias (K123508) received a 510(k) decision of Substantially Equivalent on February 26, 2014, 470 days after the submission was received.
What is the product code of K123508?
The FDA product code is OWB – Interventional Fluoroscopic X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1650.