Cleared Traditional

K943320 - HEAD AND NECK COIL FOR THE GYREX 2T-DLX

K943320 is an FDA 510(k) clearance for HEAD AND NECK COIL FOR THE GYREX 2T-DLX, manufactured by Elscint, Inc.. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K943320 · Elscint, Inc. · Radiology device
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Nov 1994
Decision
141d
Days
Class 2
Risk

K943320 is an FDA 510(k) clearance for the HEAD AND NECK COIL FOR THE GYREX 2T-DLX. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Elscint, Inc. (Hackensack, US). The FDA issued a Cleared decision on November 29, 1994 after a review of 141 days - within the typical 510(k) review window.

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 Elscint, Inc. devices

FDA 510(k) Submission Details - K943320

510(k) Number K943320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1994
Decision Date November 29, 1994
Days to Decision 141 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
34d slower than avg
Panel avg: 107d · This submission: 141d
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.

Regulatory Peers - LNH System, Nuclear Magnetic Resonance Imaging

All 997
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K943320.
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