Xoran Technologies, LLC
Ann Arbor, MI, US
Xoran Technologies, LLC appears in FDA device records in Ann Arbor, MI. FDA records list 7 510(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 7 510(k) clearances for Xoran Technologies, LLC between 2003 and 2022. The busiest year on record is 2003, with 1. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 1 |
| 2006 | 1 |
| 2008 | 1 |
| 2012 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K221230 | TRON | OWB | Substantially Equivalent | |
| K210257 | Xoran Workstation, Model 10050 | LLZ | Substantially Equivalent | |
| K201825 | MiniCAT 2D | KPR | Substantially Equivalent | |
| K113421 | MINICAT | JAK | Substantially Equivalent | |
| K073306 | XORANCONNECT | LLZ | Substantially Equivalent | |
| K061834 | XCAT; XCAT FOR NEURO | JAK | Substantially Equivalent | |
| K032243 | MINICAT DENTOCAT | JAK | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004198450 | 3004198450 | Xoran Technologies, LLC | 5210 South State Road, Ann Arbor, MI 48108 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-1210-2015 | Xoran MiniCAT X-ray imaging device | Out of tolerance kVp, Unexposed (black) frames, and Out of tolerance Dose. | Class II | Terminated | |
| Z-0040-2014 | Xoran MiniCAT00202 | The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for dose rate of 125 3 kVp. These 18 complaints received include dose rates both on the high and low end of Xorans specifications. | Class II | Terminated | |
| Z-0039-2014 | Xoran Minicat00158 | The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for dose rate of 125 3 kVp. These 18 complaints received include dose rates both on the high and low end of Xoran's specifications. See ATTACHMENT 1 for details. (e) A n evaluation of the hazards reasonably related to defect or the failure to comply with the Federal standard; An evaluation of the health ha | Class II | Terminated | |
| Z-0038-2014 | Xoran Minicat00202 | The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for dose rate of 125 3 kVp. These 18 complaints received include dose rates both on the high and low end of Xoran's specifications. See ATTACHMENT 1 for details. (e) A n evaluation of the hazards reasonably related to defect or the failure to comply with the Federal standard; An evaluation of the health ha | Class II | Terminated | |
| Z-0037-2014 | Xoran MiniCAT CT Scanner | A description of the defect in the product or the manner in which the product fails to comply wvith an applicable Federal standard; The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for dose rate of 125 3 kVp. These 18 complaints received include dose rates both on the high and low end of Xoran's specifications. See ATTACHMENT 1 for details. (e) A n evalu | Class II | Terminated | |
| Z-0036-2014 | Xoran Mini CT Scanner | A description of the defect in the product or the manner in which the product fails to comply with an applicable Federal standard; The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for dose rate of 125 3 kVp. These 18 complaints received include dose rates both on the high and low end of Xoran's specifications. See ATTACHMENT 1 for details. (e) A n evalu | Class II | Terminated | |
| Z-0041-2014 | Xoran MiniCAT CT Scanner ID ENT00001 | Failure of the gantry to rotate. The complaint alleged that the scanner would emit radiation but would not rotate. | Class II | Terminated | |
| Z-1577-2009 | XoranConnect, software version 4.1.0.6, Xoran Technologies, Ann Arbor, MI. A web-based software which provides online multi-planar image viewing, offsite data storage, administrative reporting tools, and teleradiology workflow. Server designed to store and serve stored imaging content on a RAID5 storage device. | An incorrect patient name label may appear on the screen displaying the selected patient's scan. | Terminated | ||
| Z-0561-2010 | Xoran MiniCAT System for ENT (server and work station), Xoran Technologies, Ann Arbor, MI. Cone beam CT for sinus, temporal bones, and maxillofacial imaging. | The system may overheat, causing poor image quality, interruption in image acquisition and/or damage to the system. Also, if the system is not allowed to cycle down prior to being restarted after an emergency stop, the x-ray and gantry motions will both resume. | Terminated | ||
| Z-0826-2008 | Xoran MiniCAT System for ENT (server and work station), Xoran Technologies, Ann Arbor, MI | Misbranding; These devices do not bear the manufacturer's name or address. | Terminated | ||
| Z-0296-2008 | Xoran MiniCAT for ENT, Xoran Technologies, Incorporated, Ann Arbor, MI 48103. This device is a cone beam CT scan for sinue, temporal bones and maxillofacial imaging. | The hard drive may crash, resulting in loss of data from patient CT scans. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain