Xoran Workstation, Model 10050

System, Image Processing, Radiological

Xoran Technologies LLC

The following data is part of a premarket notification filed by Xoran Technologies Llc with the FDA for Xoran Workstation, Model 10050.

Pre-market Notification Details

Device IDK210257
510k NumberK210257
Device Name:Xoran Workstation, Model 10050
ClassificationSystem, Image Processing, Radiological
Applicant Xoran Technologies LLC 5210 S. State Rd. Ann Arbor,  MI  48108
ContactMark Mcgarrow
CorrespondentMark Mcgarrow
Xoran Technologies LLC 5210 S. State Rd. Ann Arbor,  MI  48108
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-01
Decision Date2021-05-20

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