Cleared Traditional

MobileX Portable X-ray System (K180561) - FDA 510(k) Clearance

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

K180561 · Denterprise International, Inc. · Radiology device
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Apr 2018
Decision
30d
Days
Class 2
Risk

K180561 is an FDA 510(k) clearance for the MobileX Portable X-ray System. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Denterprise International, Inc. (Ormond Beach, US). The FDA issued a Cleared decision on April 4, 2018 after a review of 30 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 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 Denterprise International, Inc. devices

Submission Details

510(k) Number K180561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2018
Decision Date April 04, 2018
Days to Decision 30 days
Submission Type Traditional
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
77d faster than avg
Panel avg: 107d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EHD Unit, X-ray, Extraoral With Timer
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

510k FDA Consulting / Denterprise International, Inc.
Joyce St. Germain

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 - EHD Unit, X-ray, Extraoral With Timer

All 49
Devices cleared under the same product code (EHD) and FDA review panel - the closest regulatory comparables to K180561.
Star-X, Intraoral X-ray System
K190357 · Hdx Will Corp. · Mar 2019
RiX70 DC
K182206 · Trident S.R.L · Sep 2018
Portable X-ray System (Model: MiniX-V, Mini X-S)
K181891 · Digimed Co., Ltd. · Aug 2018
Portable X-ray System
K172928 · Rolence Enterprise, Inc. · Mar 2018
PORT-X IV
K172810 · Genoray Co., Ltd. · Mar 2018
TROPHYPAN C WITH ORTHOIMAGING/OMSIMAGING ACCESSORY
K040556 · Eastman Kodak Company · Apr 2004