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Xoran Technologies, LLC

Last updated September 17, 2026

Information

Country: US
Address: 5210 South State Road, Ann Arbor, MI, 48108
Website: —
LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3004198450
DUNS Number: —

Catalogue (23)

Device	Model / Reference	Registries	Class	Status
MiniCAT 2D	10030	FDA UDI	Class II	Active
MiniCATIQ	10009	FDA UDI	Class II	Active
Xoran Workstation	v5.15.5	FDA UDI	Class II	Active
Tron	11050	FDA UDI	Class II	Active
MiniCAT2020	10020	FDA UDI	Class II	Active
Xoran Workstation	v.5	FDA UDI	Class II	Active
xCAT XL	11010	FDA UDI	Class II	Active
XoranConnect	5.2	FDA UDI	Class II	Active
MiniCAT	10004	FDA UDI	Class II	Active
xCAT IQ	11020	FDA UDI	Class II	Active
MiniCATIQ	10015	FDA UDI	Class II	Active
xCAT	11000	FDA UDI	Class II	Active
MiniCAT 2D	10031	FDA UDI	Class II	Active
MiniCATIQ+	10040	FDA UDI	Class II	Active
XoranConnect	v.6	FDA UDI	Class II	Active
MiniCAT 2D	10035	FDA UDI	Class II	Active
Tron	K221230	FDA 510(k)	Class II	Active
Xoranconnect	K073306	FDA 510(k)	Class II	Active
Minicat Dentocat	K032243	FDA 510(k)	Class II	Active
Xoran Workstation, Model 10050	K210257	FDA 510(k)	Class II	Active
MiniCAT 2D	K201825	FDA 510(k)	Class II	Active
Xcat; Xcat For Neuro	K061834	FDA 510(k)	Class II	Active
Minicat	K113421	FDA 510(k)	Class II	Active

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FDA Recalls (11)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Sep 8, 2014	Z-1210-2015	—	terminated	Out of tolerance kVp, Unexposed (black) frames, and Out of tolerance Dose.
Jul 27, 2010	Z-0037-2014	—	terminated	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
Jul 27, 2010	Z-0040-2014	—	terminated	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.
Jul 27, 2010	Z-0039-2014	—	terminated	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
Jul 27, 2010	Z-0036-2014	—	terminated	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
Jul 27, 2010	Z-0038-2014	—	terminated	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
Dec 14, 2009	Z-0041-2014	—	terminated	Failure of the gantry to rotate. The complaint alleged that the scanner would emit radiation but would not rotate.
Feb 3, 2009	Z-1577-2009	—	terminated	An incorrect patient name label may appear on the screen displaying the selected patient's scan.
Sep 17, 2008	Z-0561-2010	—	terminated	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.
Jan 4, 2008	Z-0826-2008	—	terminated	Misbranding; These devices do not bear the manufacturer's name or address.
Jul 13, 2006	Z-0296-2008	—	terminated	The hard drive may crash, resulting in loss of data from patient CT scans.