Cleared Traditional

MODEL 4500-SMS-42 (K903822) - FDA 510(k) Clearance

Also marketed or referenced as:
SHOULDER COIL

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K903822 · Medical Advances, Inc. · Radiology device
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Oct 1990
Decision
42d
Days
Class 2
Risk

K903822 is an FDA 510(k) clearance for the MODEL 4500-SMS-42. 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 October 1, 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

Submission Details

510(k) Number K903822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1990
Decision Date October 01, 1990
Days to Decision 42 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
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 475
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K903822.
MAGNETIC RESONANCE DIAG. DEV. SPECIAL PURPOSE COIL
K905615 · Siemens Medical Solutions USA, Inc. · Feb 1991
VISTA HPQ SYSTEM
K905259 · Philips Medical Systems (Cleveland), Inc. · Jan 1991
VISTAR
K905070 · Philips Medical Systems (Cleveland), Inc. · Jan 1991
MAGNETIC RESONANCE DIAGNOSTIC DEVICE-OR 41 MAGNET
K903527 · Siemens Medical Solutions USA, Inc. · Sep 1990
TEMPOROMANDIBULAR JOINT (TMJ) COIL
K902217 · Siemens Medical Solutions USA, Inc. · Sep 1990
GE QUADRATURE T/L SPINE SURF COIL, M1085AP/M1285AP
K902663 · General Electric Co. · Sep 1990