Cleared Traditional

MODEL #QSC-200-4C AND QSC-165-4C ARRAY SHOULDER COILS (K961366) - FDA 510(k) Clearance

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

K961366 · Mri Devices Corp. · Radiology device
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Jul 1996
Decision
85d
Days
Class 2
Risk

K961366 is an FDA 510(k) clearance for the MODEL #QSC-200-4C AND QSC-165-4C ARRAY SHOULDER COILS. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Mri Devices Corp. (Waukesha, US). The FDA issued a Cleared decision on July 3, 1996 after a review of 85 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 Mri Devices Corp. devices

Submission Details

510(k) Number K961366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1996
Decision Date July 03, 1996
Days to Decision 85 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 107d · This submission: 85d
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 K961366.
IN-ROOM MRC/ MAGNETOM VISION AND IMPACT SYSTEMS
K962927 · Siemens Medical Solutions USA, Inc. · Sep 1996
QUADRATURE AND PHASED ARRAY FLEXIBLE BODY COILS
K962117 · Philips Medical Systems (Cleveland), Inc. · Aug 1996
FLEXIBLE PHASED ARRAY SPINE COIL
K960497 · Philips Medical Systems (Cleveland), Inc. · Jul 1996
KINEMATIC KNEE DEVICE/MAGNETOM OPEN SYSTEM
K961121 · Siemens Medical Solutions USA, Inc. · Jun 1996
MR GUIDED PROCEDURES PACKAGE/MAGNETOM OPEN SYSTEM
K955389 · Siemens Medical Solutions USA, Inc. · Jun 1996
MOVABLE ADD-ON COUCH FOR OUTLOOK
K960973 · Philips Medical Systems (Cleveland), Inc. · May 1996