Cleared Traditional

K915279 - NEOPROBE PORTABLE RADIOSCOPE DETECTOR (FDA 510(k) Clearance)

Class I Radiology device.

K915279 · Neoprobe Corp. · Radiology device
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Jun 1992
Decision
198d
Days
Class 1
Risk

K915279 is an FDA 510(k) clearance for the NEOPROBE PORTABLE RADIOSCOPE DETECTOR. Classified as Probe, Uptake, Nuclear (product code IZD), Class I - General Controls.

Submitted by Neoprobe Corp. (Columbus, US). The FDA issued a Cleared decision on June 10, 1992 after a review of 198 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1320 - 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 Neoprobe Corp. devices

Submission Details

510(k) Number K915279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1991
Decision Date June 10, 1992
Days to Decision 198 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
91d slower than avg
Panel avg: 107d · This submission: 198d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IZD Probe, Uptake, Nuclear
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1320
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.