Cleared Traditional

K113365 - INFANT ARRAY

K113365 is an FDA 510(k) clearance for INFANT ARRAY, manufactured by Advanced Imaging Research Dba Sree Medical Systems. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K113365 · Advanced Imaging Research Dba Sree Medical Systems · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
135d
Days
Class 2
Risk

K113365 is an FDA 510(k) clearance for the INFANT ARRAY. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Advanced Imaging Research Dba Sree Medical Systems (Cleveland, US). The FDA issued a Cleared decision on March 29, 2012 after a review of 135 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. 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 Advanced Imaging Research Dba Sree Medical Systems devices

FDA 510(k) Submission Details - K113365

510(k) Number K113365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2011
Decision Date March 29, 2012
Days to Decision 135 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 107d · This submission: 135d
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 329
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K113365.
SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646
K122897 · Invivo Corporation · Dec 2012
DS ANTERIOR, DS BASE, DS HEAD-NECK, DS HEAD, FLEX (S,M,L)
K123492 · Philips Medical Systems · Dec 2012
DS BREAST 16CH I/T 1.5T DS BREAST 16CH I/T 3.0T
K122646 · Invivo Corporation · Nov 2012
SENSE MSK S 8CH 1.5T
K120122 · Invivo Corporation · Feb 2012
1.5T AND 3T 8-CHANNEL MEDIUM GENERAL PURPOSE FLEX COIL
K111673 · Invivo Corporation · Dec 2011
TEMPOROMANIBULAR COIL 15
K110373 · Esaote, S.P.A. · Apr 2011