Orthoscan, Inc.
Medical device manufacturer in Scottsdale, AZ.
6510(k) clearances
0PMA approvals
11recalls
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K213113 | Orthoscan Tau Mini C-ArmOXO · Special | 10/21/2021SE |
| K183220 | OrthoScan TAU Mini C-ArmOXO · Traditional | 06/21/2019SE |
| K133174 | Orthoscan FD Mini C-ArmOXO · Traditional | 03/28/2014SE |
| K113708 | Orthoscan Mobile Di Mini C-ArmOXO · Traditional | 01/05/2012SE |
| K051754 | Orthoscan, Orthoscan HDOXO · Traditional | 08/09/2005SE |
| K011827 | Ortelius 800KQX · Traditional | 08/28/2001SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0579-2025 Class II | Ziehm Vision RFD 3D. Interventinoal fluoroscopic x-ray systemZiehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed… | 08/08/2024Open, Classified |
| Z-0578-2025 Class II | Ziehm Vision RFD. Interventional fluoroscopic x-ray systemZiehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed… | 08/08/2024Open, Classified |
| Z-0577-2025 Class II | Ziehm Vision R. Iterventional fluoroscopic x-ray systemZiehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed… | 08/08/2024Open, Classified |
| Z-0576-2025 Class II | Ziehm Vision FD. Interventional fluoroscopic x-ray systemZiehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed… | 08/08/2024Open, Classified |
| Z-0575-2025 Class II | Ziehm Vision system, x-ray, tomography, computed.Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed… | 08/08/2024Open, Classified |
| Z-0574-2025 Class II | Ziehm Solo FD. Interventional fluoroscopic x-ray systemZiehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed… | 08/08/2024Open, Classified |
| Z-0573-2025 Class II | Ziehm Solo. Digital Mobile C-armZiehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed… | 08/08/2024Open, Classified |
| Z-0261-2018 Class II | Mobile Mini C-arm system Part # 1000-0004-FD. Intended to provide the physician with…OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices.… | 08/31/2017Terminated |
| Z-0260-2018 Class II | Mobile Mini C-arm system Part # 1000-0005. Intended to provide the physician with…OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices.… | 08/31/2017Terminated |
| Z-0259-2018 Class II | Mobile Mini C-arm system Part # 1000-0004. Intended to provide the physician with…OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices.… | 08/31/2017Terminated |
| Z-0258-2018 Class II | Mobile Mini C-arm system Part # 1000-0001. Intended to provide the physician with…OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices.… | 08/31/2017Terminated |