Cleared Special

K001713 - HRW-42 WRIST ARRAY COIL FOR 1.0 TESLA

K001713 is the FDA 510(k) clearance for HRW-42 WRIST ARRAY COIL FOR 1.0 TESLA by Mri Devices Corp.. It is a Class 2 Radiology device (product code MOS) cleared through the Special 510(k) pathway after a 9-day FDA review.

K001713 · Mri Devices Corp. · Radiology device
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Jun 2000
Decision
9d
Days
Class 2
Risk

K001713 is an FDA 510(k) clearance for the HRW-42 WRIST ARRAY COIL FOR 1.0 TESLA. 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 June 14, 2000 after a review of 9 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 K001713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2000
Decision Date June 14, 2000
Days to Decision 9 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
98d faster than avg
Panel avg: 107d · This submission: 9d
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 K001713.
HAC-300 HEAD ARRAY COIL
K001944 · Mri Devices Corp. · Aug 2000
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K001582 · Usa Instruments, Inc. · Jul 2000
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K001303 · Mri Devices Corp. · Jun 2000
HI-RES 9000 PHASED ARRAY CAROTID COIL
K001210 · Usa Instruments, Inc. · Jun 2000
SYNERGY HEAD/NECK COIL
K001331 · Philips Medical Systems North America, Inc. · Jun 2000
INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PELVIS COIL
K001209 · Usa Instruments, Inc. · Jun 2000