Cleared Traditional

MODEL #QWH-63, QUADRATURE WRIST AND HAND COIL (K931008) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K931008 · Mri Devices Corp. · Radiology device
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Jun 1993
Decision
112d
Days
Class 2
Risk

K931008 is an FDA 510(k) clearance for the MODEL #QWH-63, QUADRATURE WRIST AND HAND COIL. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Mri Devices Corp. (Waukesha, US). The FDA issued a Cleared decision on June 18, 1993 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Mri Devices Corp. devices

Submission Details

510(k) Number K931008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1993
Decision Date June 18, 1993
Days to Decision 112 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 107d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LNH System, Nuclear Magnetic Resonance Imaging
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 - LNH System, Nuclear Magnetic Resonance Imaging

All 475
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K931008.
MAG RESON DIAG DEVI ACCESS CIR POLAR(CP) HEAD COIL
K932374 · Siemens Medical Solutions USA, Inc. · Sep 1993
MAG RES DIAG DEV ACCESS CIR POL(CP) BODY/SPINE COI
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MAGNETOM P8
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MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K924605 · General Electric Co. · May 1993
VISTA HP/HPQ SYSTEM
K925845 · Philips Medical Systems (Cleveland), Inc. · Feb 1993
SOFTWARE VERSION A2.5 FOR MAGNETOM 42SP/63SP SYST
K924489 · Siemens Medical Solutions USA, Inc. · Jan 1993