510(k) K190146

Nexus DR Digital X-ray Imaging System by Varex Imaging Corporation — Product Code MQB

K190146 is an FDA 510(k) premarket notification submitted by Varex Imaging Corporation for the device "Nexus DR Digital X-ray Imaging System". The FDA issued a decision of Substantially Equivalent on March 8, 2019. The device falls under product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)), a Class II device regulated under 21 CFR 892.1680. Varex Imaging Corporation has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 2019
Date Received
January 29, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type