Cleared Special

K190146 - Nexus DR Digital X-ray Imaging System

K190146 is the FDA 510(k) clearance for Nexus DR Digital X-ray Imaging System by Varex Imaging Corporation. It is a Class 2 Radiology device (product code MQB) cleared through the Special 510(k) pathway after a 38-day FDA review.

K190146 · Varex Imaging Corporation · Radiology device
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Mar 2019
Decision
38d
Days
Class 2
Risk

K190146 is an FDA 510(k) clearance for the Nexus DR Digital X-ray Imaging System. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Varex Imaging Corporation (Liverpool, US). The FDA issued a Cleared decision on March 8, 2019 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Varex Imaging Corporation devices

Submission Details

510(k) Number K190146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2019
Decision Date March 08, 2019
Days to Decision 38 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 107d · This submission: 38d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MQB Solid State X-ray Imager (flat Panel/digital Imager)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - MQB Solid State X-ray Imager (flat Panel/digital Imager)

All 218
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