Cleared Traditional

K942580 - NEOPROBE 1000 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES (FDA 510(k) Clearance)

Class I Radiology device.

K942580 · Neoprobe Corp. · Radiology device
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Optimized for regulatory review, auditing and printing
Feb 1995
Decision
254d
Days
Class 1
Risk

K942580 is an FDA 510(k) clearance for the NEOPROBE 1000 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES. Classified as Probe, Uptake, Nuclear (product code IZD), Class I - General Controls.

Submitted by Neoprobe Corp. (Dublin, US). The FDA issued a Cleared decision on February 9, 1995 after a review of 254 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 K942580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1994
Decision Date February 09, 1995
Days to Decision 254 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
147d slower than avg
Panel avg: 107d · This submission: 254d
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.