Cleared Special

K082987 - HRK-63-16 KNEE ARRAY COIL, HRK-127-16 KNEE ARRAY COIL

K082987 is an FDA 510(k) clearance for HRK-63-16 KNEE 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 30-day FDA review.

K082987 · Invivo · Radiology device
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Nov 2008
Decision
30d
Days
Class 2
Risk

K082987 is an FDA 510(k) clearance for the HRK-63-16 KNEE ARRAY COIL, HRK-127-16 KNEE 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 6, 2008 after a review of 30 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.

FDA 510(k) Submission Details - K082987

510(k) Number K082987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2008
Decision Date November 06, 2008
Days to Decision 30 days
Submission Type Special
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 107d · This submission: 30d
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 489
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K082987.
ECHELON HIGH RESOLUTION FOOT COIL (MR-HRF-150), ECHELON LONG BONE COIL (MR-LBC-150)
K083086 · Hitachi Medical Systems America, Inc. · Dec 2008
16CH AI BREAST COILS 1.5 T AND 3 T
K083255 · Rapid Biomedical GmbH · Nov 2008
1.5T ATLAS SPEEDER HEAD-NECK COIL
K083160 · Quality Electrodynamics · Nov 2008
ATLAS SPEEDER HEAD/CERVICAL COIL, MODEL MJAH-137A
K083014 · Toshiba America Medical Systems, In.C · Oct 2008
HRB-127-32 HIGH RESOLUTION BRAIN COIL
K082916 · Invivo · Oct 2008
TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3T
K082636 · Quality Electrodynamics · Sep 2008
K082987 · HRK-63-16 KNEE ARRAY COIL, HRK-127-16 KNEE ARRAY COIL
Download PDF Invivo