Cleared Traditional

K160346 - MX30N(MX30TQS)

K160346 is the FDA 510(k) clearance for MX30N(MX30TQS) by Wide Corporation. It is a Class 2 Radiology device (product code PGY) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K160346 · Wide Corporation · Radiology device
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Apr 2016
Decision
66d
Days
Class 2
Risk

K160346 is an FDA 510(k) clearance for the MX30N(MX30TQS). Classified as Display, Diagnostic Radiology (product code PGY), Class II - Special Controls.

Submitted by Wide Corporation (Yongin-Si, KR). The FDA issued a Cleared decision on April 14, 2016 after a review of 66 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 Wide Corporation devices

Submission Details

510(k) Number K160346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2016
Decision Date April 14, 2016
Days to Decision 66 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
41d faster than avg
Panel avg: 107d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 83
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