Cleared Special

KFA-63 KNEE AND FOOT ARRAY (K000935) - FDA 510(k) Clearance

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K000935 · Mri Devices Corp. · Radiology device
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Apr 2000
Decision
15d
Days
Class 2
Risk

K000935 is an FDA 510(k) clearance for the KFA-63 KNEE AND FOOT ARRAY. 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 April 7, 2000 after a review of 15 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Mri Devices Corp. devices

Submission Details

510(k) Number K000935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2000
Decision Date April 07, 2000
Days to Decision 15 days
Submission Type Special
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 107d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

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 90
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K000935.
8 CHANNEL CARDIAC PHASED ARRAY COIL
K022669 · GE Medical Systems · Sep 2002
3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL
K003613 · GE Medical Systems · Apr 2001
SIGNA SP 0.5T ROTATING HORIZONTAL BODY COIL
K003946 · GE Medical Systems · Feb 2001
CP PERIPHERAL ANGIO ARRAY COIL/ MAGNETOM SYMPHONY SYSTEM
K994315 · Siemens Medical Solutions USA, Inc. · Feb 2000
SIGNA 1.5T PHOSPHORUS (P) TRANSMIT/RECEIVE FLEX COIL
K983139 · GE Medical Systems · Feb 1999
PHASED ARRAY FLEXIBLE CARDIAC COIL
K984588 · Philips Medical Systems (Cleveland), Inc. · Feb 1999