510(k) K210257

Xoran Workstation, Model 10050 by Xoran Technologies, LLC — Product Code LLZ

K210257 is an FDA 510(k) premarket notification submitted by Xoran Technologies, LLC for the device "Xoran Workstation, Model 10050". The FDA issued a decision of Substantially Equivalent on May 20, 2021. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Xoran Technologies, LLC has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2021
Date Received
February 1, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type