Cleared Special

K193238 - Nexus DR Digital X-Ray Imaging System (with vSharp)

K193238 is an FDA 510(k) clearance for Nexus DR Digital X-Ray Imaging System (..., manufactured by Varex Imaging Corporation. The device is a Class 2 Radiology device with product code MQB cleared through the Special 510(k) pathway after a 25-day FDA review.

K193238 · Varex Imaging Corporation · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2019
Decision
25d
Days
Class 2
Risk

K193238 is an FDA 510(k) clearance for the Nexus DR Digital X-Ray Imaging System (with vSharp). 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 December 20, 2019 after a review of 25 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.

FDA 510(k) Submission Details - K193238

510(k) Number K193238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2019
Decision Date December 20, 2019
Days to Decision 25 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
82d faster than avg
Panel avg: 107d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

MQB Device Classification - Class 2, Special Controls

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 423
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K193238 · Nexus DR Digital X-Ray Imaging System (with vSharp)
Download PDF FDA Summary Varex Imaging Corpora…