Cleared Traditional

K181498 - X-ray Imaging System for the McLaren Pr...

K181498 is the FDA 510(k) clearance for X-ray Imaging System for the McLaren Pr... by Ehmetdx, LLC. It is a Class 2 Radiology device (product code LHN) cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K181498 · Ehmetdx, LLC · Radiology device
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Dec 2018
Decision
186d
Days
Class 2
Risk

K181498 is an FDA 510(k) clearance for the X-ray Imaging System for the McLaren Proton Treatment System. Classified as System, Radiation Therapy, Charged-particle, Medical (product code LHN), Class II - Special Controls.

Submitted by Ehmetdx, LLC (Plymouth, US). The FDA issued a Cleared decision on December 10, 2018 after a review of 186 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - 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 Ehmetdx, LLC devices

Submission Details

510(k) Number K181498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2018
Decision Date December 10, 2018
Days to Decision 186 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
79d slower than avg
Panel avg: 107d · This submission: 186d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LHN System, Radiation Therapy, Charged-particle, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
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 - LHN System, Radiation Therapy, Charged-particle, Medical

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