Cleared Traditional

K944773 - MODEL 405GE-64: PHASED ARRAY TMJ COIL

K944773 is an FDA 510(k) clearance for MODEL 405GE-64: PHASED ARRAY TMJ COIL, 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 120-day FDA review.

K944773 · Medical Advances, Inc. · Radiology device
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Jan 1995
Decision
120d
Days
Class 2
Risk

K944773 is an FDA 510(k) clearance for the MODEL 405GE-64: PHASED ARRAY TMJ COIL. 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 January 25, 1995 after a review of 120 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 Medical Advances, Inc. devices

FDA 510(k) Submission Details - K944773

510(k) Number K944773 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1994
Decision Date January 25, 1995
Days to Decision 120 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
13d slower than avg
Panel avg: 107d · This submission: 120d
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 K944773.
MODEL 528GE SERIES
K944331 · Medical Advances, Inc. · Jan 1995
GENERAL PURPOSE FLEX COIL
K944469 · Philips Medical Systems (Cleveland), Inc. · Jan 1995
FLEXART QD BODY COIL
K944662 · Toshiba America Mri, Inc. · Jan 1995
2D,3D, TOF MR ANGIOGRAPHY
K943800 · Hitachi Medical Systems America, Inc. · Dec 1994
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K944112 · GE Medical Systems · Dec 1994
MERIT (O.1T MR SYSTEM)
K943415 · Philips Medical Systems (Cleveland), Inc. · Dec 1994