Cleared Traditional

K021631 - ISA-21 INTERVENTIONAL SPINE ARRAY COIL

K021631 is the FDA 510(k) clearance for ISA-21 INTERVENTIONAL SPINE 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 88-day FDA review.

K021631 · Mri Devices Corp. · Radiology device
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Aug 2002
Decision
88d
Days
Class 2
Risk

K021631 is an FDA 510(k) clearance for the ISA-21 INTERVENTIONAL SPINE 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 August 13, 2002 after a review of 88 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 K021631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2002
Decision Date August 13, 2002
Days to Decision 88 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
19d faster than avg
Panel avg: 107d · This submission: 88d
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 K021631.
MODEL EXS-63-INT SMALL EXTREMITY ARRAY COIL
K022487 · Mri Devices Corp. · Aug 2002
MODEL OBC-63 BREAST ARRAY COIL
K022488 · Mri Devices Corp. · Aug 2002
ALTAIRE MAGNETIC RESONANCE IMAGING SYSTEM
K021751 · Hitachi Medical Systems America, Inc. · Aug 2002
HRH-127-8 HEAD ARRAY COIL
K022372 · Mri Devices Corp. · Aug 2002
MAGNETOM TRIO QUADRATURE TX/RX HEAD COIL
K021330 · Usa Instruments, Inc. · Jul 2002
MILLENNIUM 5000 MEUROVASCULAR COIL
K021141 · Usa Instruments, Inc. · Jun 2002