Cleared Special

MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL (K023596) - FDA 510(k) Clearance

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K023596 · Medrad, Inc. · Radiology device
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Nov 2002
Decision
11d
Days
Class 2
Risk

K023596 is an FDA 510(k) clearance for the MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Medrad, Inc. (Indianola, US). The FDA issued a Cleared decision on November 8, 2002 after a review of 11 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 Medrad, Inc. devices

Submission Details

510(k) Number K023596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2002
Decision Date November 08, 2002
Days to Decision 11 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 107d · This submission: 11d
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 77
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K023596.
OR HEAD COIL 1.5 T
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K031095 · Philips Medical Systems (Cleveland), Inc. · Jun 2003
CP PERIPHERAL ANGIO ARRAY COIL/ MAGNETOM SYMPHONY SYSTEM
K994315 · Siemens Medical Solutions USA, Inc. · Feb 2000
PHASED ARRAY FLEXIBLE CARDIAC COIL
K984588 · Philips Medical Systems (Cleveland), Inc. · Feb 1999
OUTLOOK LARGE PHASED ARRAY NECK COIL
K981959 · Philips Medical Systems (Cleveland), Inc. · Jul 1998