Cleared Traditional

K162196 - Dell UP3216Q with QUBYX PerfectLum bundle

K162196 is an FDA 510(k) clearance for Dell UP3216Q with QUBYX PerfectLum bundle, manufactured by Qubyx Software Technologies, Inc.. The device is a Class 2 Radiology device with product code PGY cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K162196 · Qubyx Software Technologies, Inc. · Radiology device
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Aug 2016
Decision
10d
Days
Class 2
Risk

K162196 is an FDA 510(k) clearance for the Dell UP3216Q with QUBYX PerfectLum bundle. Classified as Display, Diagnostic Radiology (product code PGY), Class II - Special Controls.

Submitted by Qubyx Software Technologies, Inc. (Wilmington, US). The FDA issued a Cleared decision on August 15, 2016 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Qubyx Software Technologies, Inc. devices

FDA 510(k) Submission Details - K162196

510(k) Number K162196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2016
Decision Date August 15, 2016
Days to Decision 10 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
97d faster than avg
Panel avg: 107d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PGY Device Classification - Class 2, Special Controls

Product Code PGY Display, Diagnostic Radiology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
Definition The Device Is Intended For Use In Displaying Radiological Images For Review, Analysis, And Diagnosis By Trained Medical Practitioners.
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 - PGY Display, Diagnostic Radiology

All 120
Devices cleared under the same product code (PGY) and FDA review panel - the closest regulatory comparables to K162196.
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