Cleared Traditional

K930265 - HYDROGEN SPECTROSCOPY OPTION-PROBE #M1040HS/HT (FDA 510(k) Clearance)

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

K930265 · GE Medical Systems · Radiology device
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Apr 1995
Decision
826d
Days
Class 2
Risk

K930265 is an FDA 510(k) clearance for the HYDROGEN SPECTROSCOPY OPTION-PROBE #M1040HS/HT. Classified as System, Nuclear Magnetic Resonance Spectroscopic (product code LNI), Class II - Special Controls.

Submitted by GE Medical Systems (Milwaukee, US). The FDA issued a Cleared decision on April 25, 1995 after a review of 826 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

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Submission Details

510(k) Number K930265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1993
Decision Date April 25, 1995
Days to Decision 826 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
719d slower than avg
Panel avg: 107d · This submission: 826d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LNI System, Nuclear Magnetic Resonance Spectroscopic
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.