Cleared Traditional

K931392 - ECG GATING UNIT

K931392 is an FDA 510(k) clearance for ECG GATING UNIT, 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 228-day FDA review.

K931392 · Resonex, Inc. · Radiology device
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Nov 1993
Decision
228d
Days
Class 2
Risk

K931392 is an FDA 510(k) clearance for the ECG GATING UNIT. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Resonex, Inc. (Fremont, US). The FDA issued a Cleared decision on November 2, 1993 after a review of 228 days - an extended review 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: 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 - K931392

510(k) Number K931392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1993
Decision Date November 02, 1993
Days to Decision 228 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
121d slower than avg
Panel avg: 107d · This submission: 228d
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 913
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K931392.
0.5T ASSET SYSTEM
K933835 · Philips Medical Systems (Cleveland), Inc. · Nov 1993
ECG GATING HARDWARE FOR MRP-5000 AND MRP-7000
K933645 · Hitachi Medical Systems America, Inc. · Nov 1993
PHILIPS GYROSCAN ACS-II RELEASE 3
K930709 · Philips Medical Systems, Inc. · Nov 1993
ACCESS MAGNETIC RESONANCE DEVICE ACCESSORY
K930960 · Toshiba America Mri, Inc. · Nov 1993
PHILIPS MRI BREAST COIL
K926275 · Philips Medical Systems, Inc. · Oct 1993
MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES
K932344 · Siemens Medical Solutions USA, Inc. · Oct 1993