Cleared Traditional

K161459 - Nexus DRTM Digital X-ray Imaging System...

K161459 is an FDA 510(k) clearance for Nexus DRTM Digital X-ray Imaging System..., manufactured by Varian Medical Systems, X-Ray Products-Infimed. The device is a Class 2 Radiology device with product code MQB cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K161459 · Varian Medical Systems, X-Ray Products-Infimed · Radiology device
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Sep 2016
Decision
103d
Days
Class 2
Risk

K161459 is an FDA 510(k) clearance for the Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4). Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Varian Medical Systems, X-Ray Products-Infimed (Liverpool, US). The FDA issued a Cleared decision on September 6, 2016 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Varian Medical Systems, X-Ray Products-Infimed devices

FDA 510(k) Submission Details - K161459

510(k) Number K161459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2016
Decision Date September 06, 2016
Days to Decision 103 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 107d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 287
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K161459.
1717WCC / 1717WGC
K162519 · Rayence Co., Ltd. · Oct 2016
SKR 3000
K162504 · Konica Minolta, Inc. · Oct 2016
DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s)
K161368 · Agfa Healthcare N.V. · Sep 2016
SCATTER CORRECTION FOR CXDI SERIES
K153312 · Canon, Inc. · Jun 2016
FDR D-EVO flat Panel Detector System
K153464 · Fujifilm Medical Systems U.S.A, Inc. · Apr 2016
VIVIX-S 1012N
K152855 · Vieworks Co., Ltd. · Feb 2016