Cleared Traditional

K945778 - PHASED ARRAY SHOULDER COIL

K945778 is the FDA 510(k) clearance for PHASED ARRAY SHOULDER COIL by Medical Advances, Inc.. It is a Class 2 Radiology device (product code LNH) cleared through the Traditional 510(k) pathway after a 118-day FDA review.

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
Combination Product No
PCCP Authorized No
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 817
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K945778.
ECHO PLANAR IMAGING I
K945828 · Philips Medical Systems (Cleveland), Inc. · Apr 1995
FLEXART(TM) QD C-SPINE COIL
K945665 · Toshiba America Mri, Inc. · Apr 1995
MRT-35A UPGRADE 8.0CD
K945798 · Toshiba America Mri, Inc. · Apr 1995
STRATIS
K945386 · Hitachi Medical Systems America, Inc. · Mar 1995
ANGIO II
K945397 · Philips Medical Systems (Cleveland), Inc. · Feb 1995
ACCESS(TM) COMPASS BED
K946244 · Toshiba America Mri, Inc. · Feb 1995