Cleared Special

K072873 - LBS-63-16 BREAST ARRAY COIL

K072873 is an FDA 510(k) clearance for LBS-63-16 BREAST ARRAY COIL, manufactured by Invivo. The device is a Class 2 Radiology device with product code MOS cleared through the Special 510(k) pathway after a 38-day FDA review.

K072873 · Invivo · Radiology device
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Nov 2007
Decision
38d
Days
Class 2
Risk

K072873 is an FDA 510(k) clearance for the LBS-63-16 BREAST ARRAY COIL. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Invivo (Florida, US). The FDA issued a Cleared decision on November 16, 2007 after a review of 38 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. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Invivo devices

FDA 510(k) Submission Details - K072873

510(k) Number K072873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2007
Decision Date November 16, 2007
Days to Decision 38 days
Submission Type Special
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 107d · This submission: 38d
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 339
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K072873.
ECHELON RAPID HEAD COIL, MODEL MR-RHC-150N, ECHELON RAPID TORSO COIL, MODEL MR-RBC-150N
K081198 · Hitachi Medical Systems America, Inc. · Jun 2008
OASIS RAPID BREAST COIL, MODEL MR-IBC-120 AND OASIS RAPID NV COIL, MODEL MR-NVC-120
K080062 · Hitachi Medical Systems America, Inc. · Feb 2008
NEOCOIL 1.5T 16 CHANNEL CARDIAC-ABDOMINAL-PELVIC ARRAY COIL
K073181 · Neocoil, LLC · Nov 2007
1.5T 32-CHANNEL HEAD COIL AND 3T 32-CHANNEL HEAD COIL
K072909 · Siemens AG Medical Solutions · Oct 2007
NORAS OR HEAD HOLDER
K071179 · Siemens Medical Solutions USA, Inc. · Jun 2007
ECHELON MR-RCC-150 CARDIAC COIL
K063513 · Hitachi Medical Systems America, Inc. · Dec 2006