Cleared Traditional

K061715 - MRGFUS GENERAL PURPOSE AND BREAST COIL

K061715 is an FDA 510(k) clearance for MRGFUS GENERAL PURPOSE AND BREAST COIL, manufactured by Insightec Txsonics, Inc.. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K061715 · Insightec Txsonics, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
39d
Days
Class 2
Risk

K061715 is an FDA 510(k) clearance for the MRGFUS GENERAL PURPOSE AND BREAST COIL. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Insightec Txsonics, Inc. (Dallas, US). The FDA issued a Cleared decision on July 28, 2006 after a review of 39 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.

FDA 510(k) Submission Details - K061715

510(k) Number K061715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2006
Decision Date July 28, 2006
Days to Decision 39 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 107d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MOS Device Classification - Class 2, Special Controls

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 489
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K061715.
CTL-63 AND CTL-128 SPINE ARRAY COILS
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K061952 · Invivo · Jul 2006
INSIGHT HEAD COIL
K061281 · Insight Neuroimaging Systems, LLC · Jun 2006
3.0T PEDIATRIC HEAD AND SPINE ARRAY, MODEL 808GE3000
K061170 · Resonance Innovations, LLC · May 2006
K061715 · MRGFUS GENERAL PURPOSE AND BREAST COIL
Download PDF FDA Summary Insightec Txsonics, I…