Cleared Traditional

K910269 - 10 ADJUSTABLE BELT COIL

K910269 is an FDA 510(k) clearance for 10 ADJUSTABLE BELT COIL, manufactured by Resonex, Inc.. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K910269 · Resonex, Inc. · Radiology device
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Apr 1991
Decision
76d
Days
Class 2
Risk

K910269 is an FDA 510(k) clearance for the 10 ADJUSTABLE BELT COIL. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Resonex, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on April 8, 1991 after a review of 76 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Resonex, Inc. devices

FDA 510(k) Submission Details - K910269

510(k) Number K910269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1991
Decision Date April 08, 1991
Days to Decision 76 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 107d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LNH Device Classification - Class 2, Special Controls

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 912
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K910269.
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