Cleared Traditional

K993898 - KAC-63 KNEE ARRAY COIL

K993898 is the FDA 510(k) clearance for KAC-63 KNEE ARRAY COIL by Mri Devices Corp.. It is a Class 2 Radiology device (product code MOS) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K993898 · Mri Devices Corp. · Radiology device
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Feb 2000
Decision
80d
Days
Class 2
Risk

K993898 is an FDA 510(k) clearance for the KAC-63 KNEE ARRAY COIL. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Mri Devices Corp. (Waukesha, US). The FDA issued a Cleared decision on February 4, 2000 after a review of 80 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 K993898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1999
Decision Date February 04, 2000
Days to Decision 80 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 107d · This submission: 80d
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 K993898.
AIRIS II
K994378 · Hitachi Medical Systems America, Inc. · Mar 2000
MAGNA 5000 PHASED ARRAY CTL SPINE COIL
K000002 · Usa Instruments, Inc. · Feb 2000
MAGNA 5000 PHASED ARRAY CTL SPINE COIL
K994345 · Usa Instruments, Inc. · Feb 2000
CP PERIPHERAL ANGIO ARRAY COIL/ MAGNETOM SYMPHONY SYSTEM
K994315 · Siemens Medical Solutions USA, Inc. · Feb 2000
SHARP 9000 PHASED ARRAY BRAIN COIL
K994042 · Usa Instruments, Inc. · Jan 2000
PHASED ARRAY KNEE AND FOOT COIL
K994040 · Usa Instruments, Inc. · Jan 2000