Cleared Traditional

K093284 - 1.0T 8-CHANNEL PANORAMA BREAST ARRAY COIL

K093284 is an FDA 510(k) clearance for 1.0T 8-CHANNEL PANORAMA BREAST ARRAY COIL, manufactured by Invivo Corporation. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K093284 · Invivo Corporation · Radiology device
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Feb 2010
Decision
104d
Days
Class 2
Risk

K093284 is an FDA 510(k) clearance for the 1.0T 8-CHANNEL PANORAMA BREAST ARRAY COIL. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Invivo Corporation (Florida, US). The FDA issued a Cleared decision on February 1, 2010 after a review of 104 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 Invivo Corporation devices

FDA 510(k) Submission Details - K093284

510(k) Number K093284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2009
Decision Date February 01, 2010
Days to Decision 104 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
3d faster than avg
Panel avg: 107d · This submission: 104d
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 311
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K093284.
14-CHANNEL EXTREMITY COIL FOR MAGNETOM ESSENZA
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K100670 · Esaote, S.P.A. · Apr 2010
1.5T AND 3.0T GENERAL PURPOSE FLEX COILS
K093842 · Invivo Corporation · Mar 2010
SPECIALTY COILS FOR THE MAGNETOM ESSENZA
K083166 · Siemens Medical Solutions USA, Inc. · Jan 2009
ECHELON HIGH RESOLUTION FOOT COIL (MR-HRF-150), ECHELON LONG BONE COIL (MR-LBC-150)
K083086 · Hitachi Medical Systems America, Inc. · Dec 2008
ATLAS SPEEDER HEAD/CERVICAL COIL, MODEL MJAH-137A
K083014 · Toshiba America Medical Systems, In.C · Oct 2008