Cleared Traditional

K991115 - LINEAR SHOULDER COIL

K991115 is the FDA 510(k) clearance for LINEAR SHOULDER COIL by Medical Advances, Inc.. It is a Class 2 Radiology device (product code MOS) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K991115 · Medical Advances, Inc. · Radiology device
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Jun 1999
Decision
68d
Days
Class 2
Risk

K991115 is an FDA 510(k) clearance for the LINEAR SHOULDER COIL, MODEL 414GE-09. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Medical Advances, Inc. (Milwaukee, US). The FDA issued a Cleared decision on June 8, 1999 after a review of 68 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 K991115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1999
Decision Date June 08, 1999
Days to Decision 68 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
39d faster than avg
Panel avg: 107d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MOS Coil, Magnetic Resonance, Specialty
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 - MOS Coil, Magnetic Resonance, Specialty

All 311
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K991115.
SYNERGY SHOULDER COIL
K991765 · Philips Medical Systems North America, Inc. · Aug 1999
QUADRATURE WRIST COIL, MODEL 445PH-64
K991434 · Medical Advances, Inc. · Jul 1999
`INEAR WRIST COIL, MODEL 440GE-09
K991113 · Medical Advances, Inc. · Jun 1999
EXTRA LARGE BODY COIL FOR OPART (MRT-600)
K991057 · Toshiba America Mri, Inc. · May 1999
OPART, MODEL MRT-600
K990007 · Toshiba America Mri, Inc. · Apr 1999
SIGNA 1.5T PHOSPHORUS (P) TRANSMIT/RECEIVE FLEX COIL
K983139 · GE Medical Systems · Feb 1999