Cleared Traditional

K913325 - 40-140 SPIN ECHO FLOW COMPENSATED PULSE SEQUENCE

K913325 is an FDA 510(k) clearance for 40-140 SPIN ECHO FLOW COMPENSATED PULSE..., 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 99-day FDA review.

K913325 · Resonex, Inc. · Radiology device
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Nov 1991
Decision
99d
Days
Class 2
Risk

K913325 is an FDA 510(k) clearance for the 40-140 SPIN ECHO FLOW COMPENSATED PULSE SEQUENCE. 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 November 1, 1991 after a review of 99 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 Resonex, Inc. devices

FDA 510(k) Submission Details - K913325

510(k) Number K913325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1991
Decision Date November 01, 1991
Days to Decision 99 days
Submission Type Traditional
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
8d faster than avg
Panel avg: 107d · This submission: 99d
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 K913325.
PHILIPS RIGID VOLUME COILS
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K914019 · Hitachi Medical Systems America, Inc. · Nov 1991
SMT-100X
K911975 · Shimadzu Medical Systems · Oct 1991
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K913475 · GE Medical Systems · Oct 1991