Cleared Traditional

K141945 - ECHOSTAR COMFORT 1.5T MRI

K141945 is an FDA 510(k) clearance for ECHOSTAR COMFORT 1.5T MRI, manufactured by Alltech Medical Systems America, Inc.. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 201-day FDA review.

K141945 · Alltech Medical Systems America, Inc. · Radiology device
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Feb 2015
Decision
201d
Days
Class 2
Risk

K141945 is an FDA 510(k) clearance for the ECHOSTAR COMFORT 1.5T MRI. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Alltech Medical Systems America, Inc. (Solon, US). The FDA issued a Cleared decision on February 3, 2015 after a review of 201 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - 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 Alltech Medical Systems America, Inc. devices

FDA 510(k) Submission Details - K141945

510(k) Number K141945 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2014
Decision Date February 03, 2015
Days to Decision 201 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
94d slower than avg
Panel avg: 107d · This submission: 201d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LNH Device Classification - Class 2, Special Controls

Product Code LNH System, Nuclear Magnetic Resonance Imaging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1000
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.

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All 872
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