Orthoscan, Inc.
FDA Regulatory Profile
Orthoscan, Inc. appears in FDA public data with 11 recalls, 6 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0578-2025, Class II) was initiated on August 8, 2024. Its most recent 510(k) clearance was granted on October 21, 2021.
Summary
- Total Recalls
- 11
- 510(k) Clearances
- 6
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0578-2025 | Class II | Ziehm Vision RFD. Interventional fluoroscopic x-ray system | August 8, 2024 |
| Z-0577-2025 | Class II | Ziehm Vision R. Iterventional fluoroscopic x-ray system | August 8, 2024 |
| Z-0576-2025 | Class II | Ziehm Vision FD. Interventional fluoroscopic x-ray system | August 8, 2024 |
| Z-0574-2025 | Class II | Ziehm Solo FD. Interventional fluoroscopic x-ray system | August 8, 2024 |
| Z-0579-2025 | Class II | Ziehm Vision RFD 3D. Interventinoal fluoroscopic x-ray system | August 8, 2024 |
| Z-0575-2025 | Class II | Ziehm Vision system, x-ray, tomography, computed. | August 8, 2024 |
| Z-0573-2025 | Class II | Ziehm Solo. Digital Mobile C-arm | August 8, 2024 |
| Z-0258-2018 | Class II | Mobile Mini C-arm system Part # 1000-0001. Intended to provide the physician with general fluoro | August 31, 2017 |
| Z-0261-2018 | Class II | Mobile Mini C-arm system Part # 1000-0004-FD. Intended to provide the physician with general fluo | August 31, 2017 |
| Z-0259-2018 | Class II | Mobile Mini C-arm system Part # 1000-0004. Intended to provide the physician with general fluoro | August 31, 2017 |
| Z-0260-2018 | Class II | Mobile Mini C-arm system Part # 1000-0005. Intended to provide the physician with general fluoro | August 31, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K213113 | Orthoscan Tau Mini C-Arm | October 21, 2021 |
| K183220 | OrthoScan TAU Mini C-Arm | June 21, 2019 |
| K133174 | ORTHOSCAN FD MINI C-ARM | March 28, 2014 |
| K113708 | ORTHOSCAN MOBILE DI MINI C-ARM | January 5, 2012 |
| K051754 | ORTHOSCAN, ORTHOSCAN HD | August 9, 2005 |
| K011827 | ORTELIUS 800 | August 28, 2001 |