Cleared Special

K022372 - HRH-127-8 HEAD ARRAY COIL

K022372 is the FDA 510(k) clearance for HRH-127-8 HEAD ARRAY COIL by Mri Devices Corp.. It is a Class 2 Radiology device (product code MOS) cleared through the Special 510(k) pathway after a 22-day FDA review.

K022372 · Mri Devices Corp. · Radiology device
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Aug 2002
Decision
22d
Days
Class 2
Risk

K022372 is an FDA 510(k) clearance for the HRH-127-8 HEAD ARRAY COIL. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Mri Devices Corp. (Waukesha, US). The FDA issued a Cleared decision on August 13, 2002 after a review of 22 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 Mri Devices Corp. devices

Submission Details

510(k) Number K022372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2002
Decision Date August 13, 2002
Days to Decision 22 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
85d faster than avg
Panel avg: 107d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 K022372.
MODEL OBC-63 BREAST ARRAY COIL
K022488 · Mri Devices Corp. · Aug 2002
ALTAIRE MAGNETIC RESONANCE IMAGING SYSTEM
K021751 · Hitachi Medical Systems America, Inc. · Aug 2002
ISA-21 INTERVENTIONAL SPINE ARRAY COIL
K021631 · Mri Devices Corp. · Aug 2002
MAGNETOM TRIO QUADRATURE TX/RX HEAD COIL
K021330 · Usa Instruments, Inc. · Jul 2002
MILLENNIUM 5000 MEUROVASCULAR COIL
K021141 · Usa Instruments, Inc. · Jun 2002
MODEL 415PH-64/42: PHASED ARRAY SHOULDER COIL
K021433 · Medical Advances, Inc. · Jun 2002