510(k) K253103

Nexus DRF Digital X-ray Imaging System by Varex Imaging Corporation — Product Code JAA

K253103 is an FDA 510(k) premarket notification submitted by Varex Imaging Corporation for the device "Nexus DRF Digital X-ray Imaging System". The FDA issued a decision of Substantially Equivalent on May 29, 2026. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. Varex Imaging Corporation has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2026
Date Received
September 24, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Fluoroscopic, Image-Intensified
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type