Cleared Special

K100113 - VANGUARD BREAST MRI AUXILIARY TABLE WITH 16 CHANNEL COIL ARRAY FOR GE 3T MRI SYSTEM, MODEL 4000451-51

K100113 is an FDA 510(k) clearance for VANGUARD BREAST MRI AUXILIARY TABLE WIT..., manufactured by Sentinelle Medical, Inc.. The device is a Class 2 Radiology device with product code MOS cleared through the Special 510(k) pathway after a 98-day FDA review.

K100113 · Sentinelle Medical, Inc. · Radiology device
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Apr 2010
Decision
98d
Days
Class 2
Risk

K100113 is an FDA 510(k) clearance for the VANGUARD BREAST MRI AUXILIARY TABLE WITH 16 CHANNEL COIL ARRAY FOR GE 3T MRI .... Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Sentinelle Medical, Inc. (Toronto, Ontario, CA). The FDA issued a Cleared decision on April 22, 2010 after a review of 98 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Sentinelle Medical, Inc. devices

FDA 510(k) Submission Details - K100113

510(k) Number K100113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2010
Decision Date April 22, 2010
Days to Decision 98 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 107d · This submission: 98d
Pathway characteristics
Modification to existing cleared device.

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 338
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