Cleared Abbreviated

K232552 - TuxDeluxe (Size 1 6100B, Size 2 6101B) (FDA 510(k) Clearance)

Class II Radiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K232552 · Tuxedo Imaging, LLC · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2023
Decision
58d
Days
Class 2
Risk

K232552 is an FDA 510(k) clearance for the TuxDeluxe (Size 1 6100B, Size 2 6101B). Classified as System, X-ray, Extraoral Source, Digital (product code MUH), Class II - Special Controls.

Submitted by Tuxedo Imaging, LLC (Akron, US). The FDA issued a Cleared decision on October 20, 2023 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1800 - the FDA radiology and imaging software oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Tuxedo Imaging, LLC devices

Submission Details

510(k) Number K232552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2023
Decision Date October 20, 2023
Days to Decision 58 days
Submission Type Abbreviated
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
49d faster than avg
Panel avg: 107d · This submission: 58d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code MUH System, X-ray, Extraoral Source, Digital
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1800
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 Consultant

Kamm & Associates
Daniel Kamm

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MUH System, X-ray, Extraoral Source, Digital

All 205
Devices cleared under the same product code (MUH) and FDA review panel - the closest regulatory comparables to K232552.
SOTA Cloud Smart Sensor (1.5)
K251793 · Sota Cloud Corp. · Mar 2026
EzSensor HD, EzSensor UHD
K252570 · Qpix Solutions, Inc. · Nov 2025
Cocoon Solo (DX-7020s)
K250687 · Dexcowin Global, Inc. · Oct 2025
Digital X-Ray DentiMax Pro Imaging System
K251206 · Dentimax, Inc. · Sep 2025
VistaPano S Ceph 2.0 (VistaPano S Ceph)
K240040 · VATECH Co., Ltd. · Oct 2024
X Sensor (Model: IOS-A15IF, HDI-15DGF)
K242778 · Qpix Solutions, Inc. · Oct 2024