Cleared Traditional

PHASED ARRAY SHOULDER COIL, QUADRATURE SHOULDER COIL (K945778) - FDA 510(k) Clearance

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

K945778 · Medical Advances, Inc. · Radiology device
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Mar 1995
Decision
118d
Days
Class 2
Risk

K945778 is an FDA 510(k) clearance for the PHASED ARRAY SHOULDER COIL, QUADRATURE SHOULDER 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 March 23, 1995 after a review of 118 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 K945778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1994
Decision Date March 23, 1995
Days to Decision 118 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
11d slower than avg
Panel avg: 107d · This submission: 118d
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 K945778.
THIN-FILM CARDIAC GATING CABLE
K946085 · General Electric Co. · Jun 1995
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
K950973 · GE Medical Systems · May 1995
ECHO PLANAR IMAGING I
K945828 · Philips Medical Systems (Cleveland), Inc. · Apr 1995
ANGIO II
K945397 · Philips Medical Systems (Cleveland), Inc. · Feb 1995
ECHO PLANAR IMAGING OPTION FOR THE MAGNETOM VISION
K941622 · Siemens Medical Solutions USA, Inc. · Jan 1995
GENERAL PURPOSE FLEX COIL
K944469 · Philips Medical Systems (Cleveland), Inc. · Jan 1995