Cleared Traditional

K103274 - SENTINELLE ENDO COIL ARRAY FOR PELVIC IMAGING

K103274 is an FDA 510(k) clearance for SENTINELLE ENDO COIL ARRAY FOR PELVIC I..., manufactured by Sentinelle Medical, Inc.. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 286-day FDA review.

K103274 · Sentinelle Medical, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
286d
Days
Class 2
Risk

K103274 is an FDA 510(k) clearance for the SENTINELLE ENDO COIL ARRAY FOR PELVIC IMAGING. 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 August 18, 2011 after a review of 286 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sentinelle Medical, Inc. devices

FDA 510(k) Submission Details - K103274

510(k) Number K103274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2010
Decision Date August 18, 2011
Days to Decision 286 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
179d slower than avg
Panel avg: 107d · This submission: 286d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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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