Xoran Technologies, Inc.

FDA Regulatory Profile

Xoran Technologies, Inc. appears in FDA public data with 7 recalls, 7 510(k) clearances, 7 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1210-2015, Class II) was initiated on September 8, 2014. Its most recent 510(k) clearance was granted on July 28, 2022.

Summary

Total Recalls
7
510(k) Clearances
7
Inspections
7
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1210-2015Class IIXoran MiniCAT X-ray imaging deviceSeptember 8, 2014
Z-0039-2014Class IIXoran Minicat00158July 27, 2010
Z-0038-2014Class IIXoran Minicat00202July 27, 2010
Z-0037-2014Class IIXoran MiniCAT CT ScannerJuly 27, 2010
Z-0040-2014Class IIXoran MiniCAT00202July 27, 2010
Z-0036-2014Class IIXoran Mini CT ScannerJuly 27, 2010
Z-0041-2014Class IIXoran MiniCAT CT Scanner ID ENT00001December 14, 2009

Recent 510(k) Clearances

K-NumberDeviceDate
K221230TRONJuly 28, 2022
K210257Xoran Workstation, Model 10050May 20, 2021
K201825MiniCAT 2DNovember 20, 2020
K113421MINICATJuly 11, 2012
K073306XORANCONNECTJanuary 7, 2008
K061834XCAT; XCAT FOR NEUROAugust 7, 2006
K032243MINICAT DENTOCATOctober 2, 2003