Cleared Traditional

CAT. #4050-64 & 4065-64 SHOULDER COILS, MODIFIED (K903754) - FDA 510(k) Clearance

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

K903754 · Medical Advances, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1990
Decision
94d
Days
Class 2
Risk

K903754 is an FDA 510(k) clearance for the CAT. #4050-64 & 4065-64 SHOULDER COILS, MODIFIED. 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 26, 1990 after a review of 94 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

Submission Details

510(k) Number K903754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1990
Decision Date October 26, 1990
Days to Decision 94 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 107d · This submission: 94d
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 K903754.
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