Cleared Traditional

K183624 - Kubtec Mozart (Xpert42) (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K183624 · Kub Technologies, Inc. · Radiology device
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Jun 2019
Decision
176d
Days
Class 2
Risk

K183624 is an FDA 510(k) clearance for the Kubtec Mozart (Xpert42). Classified as Cabinet, X-ray System (product code MWP), Class II - Special Controls.

Submitted by Kub Technologies, Inc. (Stratford, US). The FDA issued a Cleared decision on June 20, 2019 after a review of 176 days - an extended review cycle.

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 Kub Technologies, Inc. devices

Submission Details

510(k) Number K183624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2018
Decision Date June 20, 2019
Days to Decision 176 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
69d slower than avg
Panel avg: 107d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MWP Cabinet, X-ray System
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 - MWP Cabinet, X-ray System

All 26
Devices cleared under the same product code (MWP) and FDA review panel - the closest regulatory comparables to K183624.
TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US)
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TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)
K230140 · Compai Healthcare (Suzhou) Co.,Ltd · Apr 2023
Solas OR
K213691 · Cirdan Imaging, Ltd. · Dec 2021
Kubtec Mozart Supra (XPERT 84) Radiography System
K210955 · Kub Technologies, Inc. · Sep 2021
Kubtec Mozart (XPERT42)
K210956 · Kub Technologies, Inc. · Aug 2021
Kubec Xpert 80 Radiography System
K210957 · Kub Technologies, Inc. · Aug 2021