Data / Medical devices / United States / Xoran Technologies, LLC
Xoran Technologies, LLC: FDA-registered device maker in Ann Arbor, MI, United States, 6 510(k) clearances
Xoran Technologies, LLC is registered with the FDA (registration 3004198450) in Ann Arbor, MI, United States. It lists 6 device types. The FDA files 6 510(k) clearances under its listings, the newest dated July 28, 2022. 10 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004198450
- Address
- 5210 South State Road, Ann Arbor, MI, United States, 48108
- Owner or operator
- Xoran Technologies LLC (10028111)
- Roles
- Complaint file establishment, Manufacturer, Remanufacturer
- First device listed
- December 30, 2008
- Registered through
- 2026
- Brand names listed
- MiniCAT, MiniCAT 2D, MiniCAT2020, MiniCATIQ, MiniCATIQ+, TRON, Xoran Technologies, Inc., Xoran Workstation and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Holder, Head, Radiographic | IWY | 1 | Manufacturer | accessdata.fda.gov |
| Image-Intensified Fluoroscopic X-Ray System, Mobile | OXO | 2 | Complaint file establishment, Manufacturer, Remanufacturer | accessdata.fda.gov |
| Interventional Fluoroscopic X-Ray System | OWB | 2 | Complaint file establishment, Manufacturer, Remanufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Complaint file establishment, Manufacturer, Remanufacturer | accessdata.fda.gov |
| System, X-Ray, Stationary | KPR | 2 | Complaint file establishment, Manufacturer, Remanufacturer | accessdata.fda.gov |
| System, X-Ray, Tomography, Computed | JAK | 2 | Complaint file establishment, Manufacturer, Remanufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 28, 2022 | K221230 | TRON | OWB | Substantially Equivalent | Xoran Technologies, LLC | accessdata.fda.gov |
| May 20, 2021 | K210257 | Xoran Workstation, Model 10050 | LLZ | Substantially Equivalent | Xoran Technologies, LLC | accessdata.fda.gov |
| November 20, 2020 | K201825 | MiniCAT 2D | KPR | Substantially Equivalent | Xoran Technologies, LLC | accessdata.fda.gov |
| July 11, 2012 | K113421 | MINICAT | JAK | Substantially Equivalent | Xoran Technologies, Inc. | accessdata.fda.gov |
| January 7, 2008 | K073306 | XORANCONNECT | LLZ | Substantially Equivalent | Xoran Technologies, Inc. | accessdata.fda.gov |
| August 7, 2006 | K061834 | XCAT; XCAT FOR NEURO | JAK | Substantially Equivalent | Xoran Technologies, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 8, 2014 | 69939 | Class II | Terminated | Xoran MiniCAT X-ray imaging device | Out of tolerance kVp, Unexposed (black) frames, and Out of tolerance Dose. | accessdata.fda.gov |
| July 27, 2010 | 66340 | Class II | Terminated | 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. | accessdata.fda.gov |
| July 27, 2010 | 66338 | Class II | Terminated | 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 st | accessdata.fda.gov |
| July 27, 2010 | 66337 | Class II | Terminated | 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 A | accessdata.fda.gov |
| July 27, 2010 | 66335 | Class II | Terminated | 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 AT | accessdata.fda.gov |
| December 14, 2009 | 66344 | Class II | Terminated | 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. | accessdata.fda.gov |
| February 3, 2009 | 52171 | Not yet classified | Terminated | 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 wo | An incorrect patient name label may appear on the screen displaying the selected patient's scan. | accessdata.fda.gov |
| September 17, 2008 | 47370 | Not yet classified | Terminated | 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. | accessdata.fda.gov |
| January 4, 2008 | 45532 | Not yet classified | Terminated | 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. | accessdata.fda.gov |
| July 13, 2006 | 45529 | Not yet classified | Terminated | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Holder, Head, Radiographic
- All makers of System, Image Processing, Radiological
- All makers of Interventional Fluoroscopic X-Ray System
- All makers of Image-Intensified Fluoroscopic X-Ray System, Mobile
- All makers of System, X-Ray, Tomography, Computed
- All makers of System, X-Ray, Stationary
Updated July 28, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.