Cleared Traditional

K901242 - MODEL 2121-64

Also marketed or referenced as:
TMJ SURFACE COIL

K901242 is an FDA 510(k) clearance for MODEL 2121-64, manufactured by Medical Advances, Inc.. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K901242 · Medical Advances, Inc. · Radiology device
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Apr 1990
Decision
42d
Days
Class 2
Risk

K901242 is an FDA 510(k) clearance for the MODEL 2121-64. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Medical Advances, Inc. (Milwaukee, US). The FDA issued a Cleared decision on April 26, 1990 after a review of 42 days - a notably fast clearance 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: 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 Medical Advances, Inc. devices

FDA 510(k) Submission Details - K901242

510(k) Number K901242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1990
Decision Date April 26, 1990
Days to Decision 42 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 107d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 817
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K901242.
MODEL 4050-21
K901864 · Medical Advances, Inc. · May 1990
ADD'L SOFTWARE VERSION D2 FOR MAGNETOM 42 AND 63
K901818 · Siemens Medical Solutions USA, Inc. · May 1990
MODEL 4050-64
K901639 · Medical Advances, Inc. · May 1990
MODEL 2121-21, TMJ SURFACE COIL
K901305 · Medical Advances, Inc. · Apr 1990
MODEL 6000-21
K901384 · Medical Advances, Inc. · Apr 1990
THORACIC/LUMBAR SPINE 8 RACETRACK COIL, 3080-64
K901241 · Medical Advances, Inc. · Apr 1990