Orthoscan, Inc.
Scottsdale, AZ, US
ORTHOSCAN, INC. appears in FDA device records in Scottsdale, AZ. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 11 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Orthoscan, Inc. between 2001 and 2021. The busiest year on record is 2001, with 1. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 1 |
| 2005 | 1 |
| 2012 | 1 |
| 2014 | 1 |
| 2019 | 1 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K213113 | Orthoscan Tau Mini C-Arm | OXO | Substantially Equivalent | |
| K183220 | OrthoScan TAU Mini C-Arm | OXO | Substantially Equivalent | |
| K133174 | ORTHOSCAN FD MINI C-ARM | OXO | Substantially Equivalent | |
| K113708 | ORTHOSCAN MOBILE DI MINI C-ARM | OXO | Substantially Equivalent | |
| K051754 | ORTHOSCAN, ORTHOSCAN HD | OXO | Substantially Equivalent | |
| K011827 | ORTELIUS 800 | KQX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005254598 | 3005254598 | ORTHOSCAN, INC. | 14555 N. 82nd Street, SCOTTSDALE, AZ 85260 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0579-2025 | Ziehm Vision RFD 3D. Interventinoal fluoroscopic x-ray system | Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit. | Class II | Open, Classified | |
| Z-0578-2025 | Ziehm Vision RFD. Interventional fluoroscopic x-ray system | Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit. | Class II | Open, Classified | |
| Z-0577-2025 | Ziehm Vision R. Iterventional fluoroscopic x-ray system | Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit. | Class II | Open, Classified | |
| Z-0576-2025 | Ziehm Vision FD. Interventional fluoroscopic x-ray system | Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit. | Class II | Open, Classified | |
| Z-0575-2025 | Ziehm Vision system, x-ray, tomography, computed. | Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit. | Class II | Open, Classified | |
| Z-0574-2025 | Ziehm Solo FD. Interventional fluoroscopic x-ray system | Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit. | Class II | Open, Classified | |
| Z-0573-2025 | Ziehm Solo. Digital Mobile C-arm | Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit. | Class II | Open, Classified | |
| Z-0261-2018 | Mobile Mini C-arm system Part # 1000-0004-FD. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures. | OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices. Specifically, the system software allows a user to activate the Digital Zoom feature in the course of taking a live image exposing a larger x-ray field than can be viewed by the user | Class II | Terminated | |
| Z-0260-2018 | Mobile Mini C-arm system Part # 1000-0005. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures. | OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices. Specifically, the system software allows a user to activate the Digital Zoom feature in the course of taking a live image exposing a larger x-ray field than can be viewed by the user | Class II | Terminated | |
| Z-0259-2018 | Mobile Mini C-arm system Part # 1000-0004. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures. | OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices. Specifically, the system software allows a user to activate the Digital Zoom feature in the course of taking a live image exposing a larger x-ray field than can be viewed by the user | Class II | Terminated | |
| Z-0258-2018 | Mobile Mini C-arm system Part # 1000-0001. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures. | OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices. Specifically, the system software allows a user to activate the Digital Zoom feature in the course of taking a live image exposing a larger x-ray field than can be viewed by the user | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain