Cleared Traditional

K930991 - BILATERAL TEMPORAL MANDIBULAR JOINT COIL

K930991 is an FDA 510(k) clearance for BILATERAL TEMPORAL MANDIBULAR JOINT COIL, manufactured by Magnetic Research, Inc.. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K930991 · Magnetic Research, Inc. · Radiology device
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Jun 1993
Decision
113d
Days
Class 2
Risk

K930991 is an FDA 510(k) clearance for the BILATERAL TEMPORAL MANDIBULAR JOINT COIL. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Magnetic Research, Inc. (Provo, US). The FDA issued a Cleared decision on June 18, 1993 after a review of 113 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 Magnetic Research, Inc. devices

FDA 510(k) Submission Details - K930991

510(k) Number K930991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1993
Decision Date June 18, 1993
Days to Decision 113 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
6d slower than avg
Panel avg: 107d · This submission: 113d
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 1004
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K930991.
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