Cleared Special

K082916 - HRB-127-32 HIGH RESOLUTION BRAIN COIL

K082916 is an FDA 510(k) clearance for HRB-127-32 HIGH RESOLUTION BRAIN 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 15-day FDA review.

K082916 · Invivo · Radiology device
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Oct 2008
Decision
15d
Days
Class 2
Risk

K082916 is an FDA 510(k) clearance for the HRB-127-32 HIGH RESOLUTION BRAIN 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 October 15, 2008 after a review of 15 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 - K082916

510(k) Number K082916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2008
Decision Date October 15, 2008
Days to Decision 15 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
92d faster than avg
Panel avg: 107d · This submission: 15d
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 K082916.
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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