Cleared Traditional

K040640 - MODEL 475 - 8 CHANNEL T/R PHASED ARRAY ...

K040640 is an FDA 510(k) clearance for MODEL 475 - 8 CHANNEL T/R PHASED ARRAY ..., manufactured by Igc-Medical Advances, Inc.. The device is a Class 2 Radiology device width product code MOS cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K040640 · Igc-Medical Advances, Inc. · Radiology device
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Mar 2004
Decision
12d
Days
Class 2
Risk

K040640 is an FDA 510(k) clearance for the MODEL 475 - 8 CHANNEL T/R PHASED ARRAY LOWER EXTREMITY COIL. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Igc-Medical Advances, Inc. (Milwaukee, US). The FDA issued a Cleared decision on March 22, 2004 after a review of 12 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 Igc-Medical Advances, Inc. devices

Submission Details

510(k) Number K040640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2004
Decision Date March 22, 2004
Days to Decision 12 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 107d · This submission: 12d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 312
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